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Domoso Gel (Canada)This page contains information on Domoso Gel for veterinary use.
The information provided typically includes the following:
- Domoso Gel Indications
- Warnings and cautions for Domoso Gel
- Direction and dosage information for Domoso Gel
Domoso GelThis treatment applies to the following species:
DIMETHYL SULFOXIDE, MEDICAL GRADE
90% w/w Dimethyl Sulfoxide
For Veterinary Use Only
Dimethyl sulfoxide (DMSO), an oxidation product of dimethyl sulfide, is an exceptional solvent possessing a number of commercial uses. DMSO is the lowest member of the group of alkyl sulfoxides with a general formula of RSOR. Its structural formula is:
It freely mixes with water with the evolution of heat and lowers the freezing point of aqueous solutions. It is soluble in many other compounds including ethanol, acetone, diethyl ether, glycerin, toluene, benzene and chloroform. DMSO is a solvent for many aromatic and unsaturated hydrocarbons as well as inorganic salts and nitrogen-containing compounds. DMSO has a high dielectric constant due to the polarity of the sulphur-oxygen bond. Its basicity is slightly greater than water due to the enhanced electron density at the oxygen atom. It forms crystalline salts with strong protic acids and coordinates with Lewis acids. It modifies hydrogen bonding.
DMSO is a hygroscopic stable organic liquid essentially odorless and water white in color. Other physical characteristics include:
Active Ingredient: DOMOSO Gel contains 90.0% w/w dimethyl sulfoxide.
The original biological applications of DMSO were primarily confined to its use in preserving various tissues and cellular elements including blood (1), blood cells and bone marrow (2), leukocytes (3), lymphocytes (4), platelets (5), spermatozoa (6, 7, 8), corneal grafts (9,10), skin (11), tissue culture cells (12, 13, 14, 15) and trypanosomes (16), by freezing techniques. DMSO has also been investigated as a radioprotective agent (17, 18).
DMSO has been stated to increase the penetration of low molecular weight allergens such as penicillin G but not large molecular weight allergens such as house dust (19).
The rate of passage of tritiated water in the presence of DMSO on the epidermis of the hairless mouse was measured in vitro. DMSO did not appear to promote the passage of water by its presence, but when concentrated solutions (60% to 100%) were used, permanent changes were produced in the rate of passage of water. It was concluded that the concentration of DMSO used seemed more significant than the time of exposure in establishing the effect on the water barrier (20).
When the tails of mice were immersed in a 5% solution of various psychoactive drugs in DMSO, the drugs appeared to exert their usual pharmacological effects indicating drug penetration as judged by the behavioral effects observed in the experimental subjects. Other solvents, including water, also appeared to permit some drug penetration in this study (21).
Using ten quaternary ammonium salts as test compounds and either water or DMSO as solvents, the oral LD50 values were determined in rats and mice. Toxicity changes were obtained in some instances by 50% DMSO and more changes were observed in rats than mice although the results in the two species were not always parallel. When toxicity was altered by DMSO it increased in all instances except one (22).
When administered systemically in another study, however, various drugs dissolved in DMSO did not differ significantly in their lethality or cellular penetration as compared to the same drugs administered in saline (23).
When evaluated as a solvent for biologic screening tests, low doses of hormones in DMSO stimulated a response similar to that of the hormone in the control vehicle. Higher doses of hormone, however, failed to give the expected response suggesting a partition coefficient in favour of the solvent (24). DMSO was also shown to carry physostigmine and phenylbutazone through the skin of the rat (25).
The absorption of phenylbutazone dissolved in an aqueous solution of DMSO was impaired when administered orally to the rabbit. Absorption of the same drug was not improved using the subcutaneous route simultaneously with DMSO. However, phenylbutazone could be detected in rabbit's blood for several hours when an ointment containing DMSO and 5% phenylbutazone was applied to the skin. When the DMSO content of the ointment was increased, the phenylbutazone levels increased. An increase of phenylbutazone in the muscle tissues underlying the site of application over a control ointment containing phenylbutazone without DMSO could be demonstrated in rats (26).
In a number of other studies in experimental animals (21, 25, 27) where DMSO has been chiefly administered orally or by injection, no anti-inflammatory or analgesic activity could be established.
Following experimental hypersensitization to human gamma-globulin, in the horse, antigen challenge resulted in massive erythema, necrosis and slough. This reaction could be markedly reduced by the hourly application of undiluted DMSO to the reaction site, after challenge (19).
DMSO, by itself, at concentrations of 100%, 66% and 33% has been shown to produce neurolysis following perineural injection in the rat's sciatic nerve (28).
The conflicting reports cited above for the anti-inflammatory and analgesic properties of DMSO are partially dependent upon the experimental models and methods used to measure these parameters. DMSO fails to show analgesic or anti-inflammatory activity in certain of these situations, particularly when used by the systemic route or when administered topically preceded by an irritant substance. In clinical studies in the horse, it was noted that when iodine, liniments or other strong irritants were present on the skin from previous therapy and DMSO applied, a temporary, but marked local reaction would occur. This was due to the ability of DMSO to carry these substances into the underlying skin tissues where their irritant actions could be displayed.
Using the isolated guinea pig heart it was found that DMSO (dimethyl sulfoxide) did not influence the amplitude of cardiac contractions, heart rate or coronary flow although high intravenous doses in the rat and cat resulted in a transient lowering of blood pressure (25).
Isolated, innervated guinea pig preparations were also used to study the effects of DMSO on skeletal, smooth and cardiac muscles. The compound depressed diaphragm response to both muscle and nerve stimulation and also caused spontaneous skeletal muscle fasciculation. Actual contraction amplitude was augmented although contraction rate appeared unaffected. Vagal threshold was lowered almost 50% by a bath concentration of 6% DMSO. The fasciculations and increased tone of skeletal muscle and lowering of the vagal threshold by DMSO could be due to cholinesterase inhibition (29).
The in vitro oxygen consumption of liver, brain and hemidiaphragm tissues of rats is not affected by the intravenous administration of 75 mg DMSO/100 g body weight during the 7 subsequent days.
Urease, trypsin and chymotrypsin are inhibited by DMSO dependent upon its concentration. The in vitro metabolism of corticosterone by rat liver slices is not affected by the intravenous administration of 100 mg DMSO/100 g of body weight during 3 subsequent days (30).
DMSO treatment administered intraperitoneally to rats for 35 days decreased experimentally induced intestinal adhesions by 80% over controls as compared to saline, cortisone acetate or a combination of cortisone and DMSO administered separately (31).
In rabbits, the application of 70% DMSO, adjacent to but not on the wound incision site, appeared to increase the development of wound tensile strength over controls (32).
Increasing the concentration of DMSO resulted in an increasing inhibition of fibroblast proliferation, in vitro, which was reversible (19).
In a study designed to evaluate the effects of DOMOSO (dimethyl sulfoxide) Solution at a total daily dose of 100-300 mL administered for a total period of 90 days, no essential or clinically meaningful ophthalmological effects were seen in the horse. There were no significant variations in glucose, sodium, potassium SGOT, or SGPT measurements. There were a few fluctuations in hematologic values but no changes appear drug-related or of significance.
Long term topical applications of the drug to guinea pigs resulted in histopathologic changes similar to those observed in allergic contact dermatitis. The observed clinical changes were compatible with either an allergic contact dermatitis or a primary irritant effect (33). DMSO was shown to cause erythema and blistering of human and rat skin resulting in increased permeability of venules and capillaries (34).
In most cases the local irritation of the skin characterized by erythema, vesicle or blister formation and scurfing abates even with continued treatment. This phenomenon has been described as “accommodation” or “hardening” of the skin, and has been noted with other solvents.
The undiluted compound has low systemic toxicity but a marked local necrotizing and inflammatory effect when it is injected subcutaneously. In rats the subcutaneous injection of 10 g/kg or the intravenous injection of 2.5 g/kg of undiluted DMSO for 2 weeks showed no definite indication of systemic toxicity. The local necrotizing effects produced at these dose levels, however, prevented a longer period of treatment. No significant hematologic or biochemical changes were noted in 3 dogs receiving 0.4 g/kg for 33 days (24).
Upon injection of DMSO in the rat pleura, there is an accumulation of fluid, initially appearing as a transudate, but later as a protein-rich exudate. Exudate formation is thought to be due to increased vascular permeability, predominantly in venules, brought about by a delayed release of histamine together with the activation of a vaso-active slow contracting substance (34).
Hemolysis resulting in hemoglobinuria and methemoglobinuria was noted in anesthetized cats following single intravenous doses of 200 mg/kg DMSO. The intraperitoneal administration of DMSO or the dilution of DMSO with isotonic saline prior to intravenous administration reduced its hemolytic activity (39).
Tests in vitro showed that washed rabbit erythrocytes are hemolyzed in a short time with 40% to 60% DMSO solutions. Higher concentrations caused, without hemolysis, an agglutination of the erythrocytes (40).
The intraperitoneal administration of 5.5 mg/kg of DMSO as a single dose to pregnant hamsters induced developmental malformations of their embryos (35).
Both dimethyl sulfoxide and diethyl sulfoxide are teratogenic when injected into the chick embryo, the classification of malformations being dependent upon the stage of embryonic development at the time of treatment. The same drugs when administered by various techniques to mice, rats and rabbits in which fertility had been established, did not cause any embryonic malformations (36).
In a variety of experimental animals including rats, dogs, swine, rabbits and primates, following oral or topical administration of DMSO, certain eye changes have been noted. These consist mainly of a change in the refractive index of the lens described as a “lens without a lens”. The lens changes are characterized by a decrease in the normal relucency of the lens cortex, causing the normal central zone of the lens to act as a biconvex lens. When viewing the fundus of affected animals, it is necessary to interpose biconcave lenses in order to see the retinal vessels clearly. The functional effect would be a tendency toward myopia (37).
The lens changes were first observed in dogs receiving 5 g DMSO/kg after 9 weeks of administration. At lower dose levels the change was observed later in rabbits these changes were seen after 90 days of dermal application, (8 mg 80% DMSO/kg/day and 4 mg 100% DMSO/kg/day and higher). In swine, dermal application of 4.5 g 90% DMSO/kg twice daily caused similar lens changes by 90 days of treatment (38).
The lens changes appear earlier with oral administration, and also bear a relation to the dosage employed; the higher the dose the more rapid their appearance.
The eye changes are slowly reversible but with a definite species difference, the dog being the slowest to exhibit improvement.
No effects were seen following direct application of aqueous solutions varying from 10% to full strength into the eyes of albino rabbits for a total dosage of DMSO between 0.1 and 0.2 g/kg body weight per day for six months. Rabbits which receive daily doses as high as 10 g/kg orally or topically showed lines of discontinuity in their lenses. No cataract was seen after tens weeks of such daily treatment although discontinuous lens lines could be detected in about two weeks by slit lamp examination. Chemical studies on these lenses revealed reduction in the usual concentrations of urea, glutathione, uric and amino acids (19).
Domoso Gel Indications
DOMOSO (dimethyl sulfoxide) Gel is recommended as a topical application to reduce acute swelling due to trauma.
Administrations And Dosage
DOMOSO Gel is to be administered topically to the skin over the affected area. Apply two to three times daily. Total daily dosage should not exceed 100 g. Total duration of therapy should not exceed 30 days.
DOMOSO Gel is contraindicated in horses with known eye diseases, liver or kidney dysfunction or horses with history of allergy.
DOMOSO Gel is contraindicated in pregnant mares or horses intended for breeding purposes.
DOMOSO Gel is restricted to topical use in horses only.
DO NOT ADMINISTER BY ANY OTHER ROUTE.
Care should be taken to ensure that the medication is evenly distributed, without excess, over the desired treatment site.
DOMOSO Gel may mask certain musculo-skeletal disease signs such as seen in fractures. This does not obviate the need for specific therapy in such conditions.
Since DOMOSO Gel effectively alters the biologic membrane and will, in some cases facilitate the systemic absorption of other topically applied drugs, it should not be used as a vehicle for other drugs. The user should make certain that other medications are not present prior to its application. If other topical medications are indicated, they should not be applied until DOMOSO Gel is thoroughly dry.
As DOMOSO Gel may have a potentiating effect on drugs administered systemically, it should be judiciously used when administered in conjunction with other pharmaceutical preparations especially those affecting the cardiovascular and central nervous systems.
DOMOSO Gel should not be used under occlusive dressings.
DOMOSO Gel is a potent solvent and may have a deleterious effect on fabrics, plastics and other materials. Care should be taken to prevent physical contact between DOMOSO Gel or DOMOSO-treated areas and these materials.
Frequently, due to the heat of resolution, a “smoking” effect following application is noted due to vaporization of the drug.
Changes in the refractive index of the lens of the eye and nuclear cataracts have been observed in animals treated with this drug. This appears to be related to dosage and duration of therapy.
In general, adverse reactions are local, and while they may prove annoying to some patients, they are usually not of a serious nature. Upon topical application, an occasional animal may develop transient erythema, associated with local “burning” or “smarting”. Even when erythema or vesiculation occur, they are self-limiting reversible states, and not necessarily indications to discontinue medication.
Dryness of the skin and an oyster-like odour have been reported. These effects are temporary and are not considered to be of serious consequence.
1. DOMOSO Gel is contraindicated for administration to horses by pregnant or lactating women, by children, by individuals with known eye disease, liver or kidney dysfunction and by individuals with a history of allergy.
2. Contact between DOMOSO Gel and the skin should be avoided. Rubber gloves should be worn while applying this drug.
3. If absorbed through the skin, DOMOSO Gel may cause mild sedation, dizziness or drowsiness in users if exposed to excessive quantities. Users showing these symptoms should not drive or operate machinery until these effects have disappeared.
4. DOMOSO Gel may cause sensations of warmth, burning, irritation, itching and mild erythematous localized dermatitis.
5. Also, if absorbed, DOMOSO Gel may cause headache and nausea.
6. Absorption of DOMOSO Gel following exposure to the skin, will result in odorous breath and an unpleasant mouth taste. Treatment of such side effects is symptomatic.
7. Consult a physician immediately if adverse effects occur.
8. DOMOSO Gel must not be administered to horses that are to be slaughtered for use in food.
9. Keep DOMOSO Gel out of the reach of children.
HYGROSCOPIC. CLOSE CAP TIGHTLY AFTER USE. AVOID FREEZING.
DOMOSO Gel. 120 g collapsible tubes.
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2. Pyle, H.M. and Boyer, H.F., EFFECTS OF DIMETHYL SULFOXIDE ON BLOOD CELLS AND BONE MARROW. Vox Sang 6, 199-200 1961
3. Rowe, A.W., Kaczmarek, C.S. and Cohen, E., LOW TEMPERATURE PRESERVATION OF LEUKOCYTES IN DIMETHYL SULFOXIDE. Federation of American Societies for Experimental Biology, 47th Annual Meeting. 16-20 Apr 1963. Atlantic City 1963 Fed. Proc. 22, 170 1963 Abstr. No. 60
4. Ashwood-Smith, M.J., LOW TEMPERATURE PRESERVATION OF MOUSE LYMPHOCYTES WITH DIMETHYL SULFOXIDE. 1964 Blood 23, 494-501 Apr 1964
5. Djerassi, I. and Roy, A., A METHOD FOR PRESERVATION OF VIABLE PLATELETS, COMBINED EFFECTS OF SUGARS AND DIMETHYL SULFOXIDE. 1963 Blood 22, 703-717 1963
6. Sawada, Y. and Chang, M.C., MOTILITY AND FERTILIZING CAPACITY OF RABBIT SPERMATOZOA AFTER FREEZING IN A MEDIUM CONTAINING DIMETHYL SULFOXIDE. 1964 Fertil. Steril. 15, 222-229 Mar-Apr 1964
7. Zimmerman, S.J., Maude, M.B. and Moldawer, M., FREEZING AND STORAGE OF HUMAN SEMEN IN 50 HEALTHY MEDICAL STUDENTS. A Comparative Study of Glycerol and Dimethyl-sulfoxide as a Preservative. 1964 Fertil. Steril. 15, 505-510 Sep-Oct 1964
8. Sherman, J.K., DIMETHYL SULFOXIDE AS A PROTECTIVE AGENT DURING FREEZING AND THAWING OF HUMAN SPERMATOZOA. 1964 Proc. Soc. Exp. Biol. Med. 177, 261-264 1964
9. Mueller, F.O., Casey, T.A. and Trevor-Roper, P.D., USE OF DEEP-FROZEN HUMAN CORNEA IN FULL-THICKNESS GRAFTS. 1964 Brit. Med. J. No. 5407, 473-475 22 Aug 1964
10. Plattz, S. and Reed, H., USE OF DIMETHYL SULFOXIDE FOR PRESERVING CORNEAL TISSUE. 1963 Brit. J. Ophthal. 47, 334-338 1963
11. Barlyn, L.W., Berggren, R.B. and Lehr, H.B., FROZEN SKIN AUTOGRAFTS PROTECTED BY DIMETHYL SULFOXIDE. 1964 Surg. Forum 15, 475-476 1964
12. Nagington, J. and Greaves, R.I., PRESERVATION OF TISSUE CULTURE CELLS WITH LIQUID NITROGEN. 1962 Nature 194, 993-994 9 Jun 1962
13. Porterfield, J.S. and Ashwood-Smith, M.J., PRESERVATION OF CELLS IN TISSUE CULTURE BY GLYCEROL AND DIMETHYL SULFOXIDE. 1962 Nature 193, 548-550 10 Feb 1962
14. Lovelock, J.E. and Bishop, M.W., PREVENTION OF FREEZING DAMAGE TO LIVING CELLS BY DIMETHYL SULFOXIDE. 1959 Nature 183, 1394-1395 16 May 1959
15. Dougherty, R.M., USE OF DIMETHYL SULFOXIDE FOR PRESERVATION OF TISSUE CULTURE CELLS BY FREEZING. 1962 Nature 193, 550-552 10 Feb 1962
16. Walker, P.J. and Ashwood-Smith, M.J., DIMETHYL SULFOXIDE, AN ALTERNATIVE TO GLYCEROL, FOR THE LOW-TEMPERATURE PRESERVATION OF TRYPANOSOMES. 1961 Ann. Trop. Med. Parasit. 55, 93-96 1961
17. Ashwood-Smith, M.J., INABILITY OF DIMETHYL SULFOXIDE TO PROTECT MOUSE TESTIS AGAINST THE EFFECT OF X-RADIATION. 1961 Int. J. Radiat. Biol. 3, 101-103 1961
18. Ashwood-Smith, M.J., RADIOPROTECTIVE EFFECT OF COMBINATION OF AET OR CYSTEAMINE WITH DIMETHYL SULFOXIDE. 1962 Int. J. Radiat. Biol. 5, 201-202 May 1962
19. Leake, C.D., DIMETHYL SULFOXIDE. Science 152, 1646-1649 17 Jun 1966
20. Sweeney, T.M., Downes, A.M. and Matoltsy, A.G., THE EFFECT OF DIMETHYL SULFOXIDE ON THE EPIDERMAL WATER BARRIER. 1966 J. Invest. Derm. 46, 300-302 Mar 1966
21. Horita, A. and Weber, L.J., SKIN PENETRATING PROPERTY OF DRUGS DISSOLVED IN DIMETHYL SULFOXIDE, (DMSO), AND OTHER VEHICLES. 1964 Life Sci. 3, 1389-1395 Dec 1964
22. Rosen, H., Blumenthal, A., Panasevich, R. and McCallum, J., DIMETHYL SULFOXIDE (DMSO) AS A SOLVENT IN ACUTE TOXICITY DETERMINATIONS. 1965 Proc. Soc. Exp. Biol. Med. 120, 511-514 Nov 1965
23. Dixon, R.L., Adamson, R.H., Ben, M. and Rall, D.P., APPARENT LACK OF INTERACTION BETWEEN DIMETHYL SULFOXIDE AND A VARIETY OF DRUGS. 1965 Proc. Soc. Exp. Biol. Med. 118, 756-759 Mar 1965
24. Rosenkrantz, H., Hadidian, Z., Seay, H. and Mason, M.M., DIMETHYL SULFOXIDE, ITS STEROID SOLUBILITY AND ENDOCRINOLOGIC AND PHARMACOLOGIC-TOXICOLOGIC CHARACTERISTICS. 1963 Cancer Chemother. Rep. No. 31, 7-24 Sep 1963
25. Haeusler, G. and Jahn, U., UNTERSUCHUNGEN ZUR PHARMAKOLOGIE VON DIMETHYLSULFOXYD (DMSO). 1966 Arch. Int. Pharmacodyn 159, 386-400 Feb 1966
26. Pantio, M. and Kaerki, N.T., THE INFLUENCE OF DIMETHYL-SULFOXIDE ON THE ABSORPTION OF PHENYLBUTAZONE. Spanish Translation. 1965 Air 8, 133-147 1965
27. Preziosi, P. and Scapagnini, U., ACTION OF DIMETHYL SULFOXIDE ON ACUTE INFLAMMATORY REACTIONS. 1966 Curr. Ther. Res. 8, 261-264 May 1966
28. Katz, J., Knott, L.W. and Rubinstein, L.J., THE NEUROHISTOLOGICAL CHANGES INDUCED BY PHENOL, DIMETHYL SULFOXIDE, AND HYALURONIDASE ON THE SCIATIC NERVE OF THE RAT. Special Abstract From Fall Pharmacology Meeting April 1966
29. Sams, W.M., Carroll, N.V. and Crantz, P.L., EFFECTS OF DIMETHYL SULFOXIDE ON ISOLATED-INNERVATED SKELETAL, SMOOTH, AND CARDIAC MUSCLE. 1966 Proc. Soc. Exp. Biol. Med. 122, 103-107 May 1966
30. Gerhards, E., Gibian, H. and Raspe, G., STOFFWECHSEL UND STOFFWECHSEL-WIRKUNGEN VON DIMETHYLSULFOXID. 1965 Arzneimittelforschung 15 1295-1297 Nov 1965
31. Mayer, J.H., Anido, H., Almond, C.H. and Seaber, A., DIMETHYL SULFOXIDE IN PREVENTION OF INTESTINAL ADHESIONS. 1965 Arch. Surg., Chicago, 91, 920-923 Dec 1965
32. Huu, N. and Albert, H.M., EFFECT OF DMSO ON WOUND HEALING TENSILE STRENGTH MEASUREMENTS IN RABBITS. 1966 Amer. Surg. 32, 421-424 Jun 1966
33. Wright, E.T. and Winer, L.H., TOPICAL APPLICATION OF DIMETHYL SULFOXIDE (DMSO) TO SKIN OF GUINEA PIGS, A Histopathological Study. 1966 J. Invest. Derm. 46, 409-414 Apr 1966
34. Willoughby, D.A., Walters, M.N. and Spector, W.G., AN ANALYSIS OF THE IRRITANT ACTION OF DIMETHYL SULFOXIDE. 1966 J. Path. Bact. 91, 195-205 Jan 1966
35. Marin-Padilla, M., MESODERMAL ALTERATIONS INDUCED BY DIMETHYL SULFOXIDE. 1966 Proc. Soc. Exp. Biol. Med. 122, 717-720 Jul 1966
36. Caujolle, F., Caujolle, D., Cros. S., Calvert, M. and Tollon, Y., TERATOGENESE POUVOIR TERATOGENE DU DIMETHYLSULFOXIDE ET DU DIETHYLSULFOXYDE. TERATOGENESIS-TESTS OF THE TERATOGENY OF DIMETHYL SULFOXIDE AND OF DIETHYL SULFOXIDE. 1965 C.R. Acad. Sci. Paris, 260, 327-330 4 Jan 1965
37. Rubin, L.F. and Mattis, P.A., DIMETHYL SULFOXIDE, LENS CHANGES IN DOGS DURING ORAL ADMINISTRATION. 1966 Science 153, 83-84 1 Jul 1966
38. Unpublished data 1966
39. DiStefano, V. and Klahn, J.J., OBSERVATIONS ON THE PHARMACOLOGY AND HEMOLYTIC ACTIVITY OF DIMETHYL SULFOXIDE. 1965 Toxic. Appl. Pharmacol. 7, 660-666 Sep 1965
40. Sommer, S. and Tauberger, G., TOXIKOLOGISCHE UNTERSUCHUNGEN MIT DIMETHYLSULFOXYD. TOXICOLOGIC INVESTIGATIONS WITH DIMETHYL SULFOXIDE. 1964 Arzneimittelforschung 14, 1050-1053 1964
Trademarks used under license
Wyeth Animal Health, Division of Wyeth Canada, Guelph, Ontario, Canada
New September 1997
NAC No.: 11983661
16,740 TRANS-CANADA HIGHWAY, KIRKLAND, QC, H9H 4M7
|Technical Services Canada:||800-461-0917|
|Technical Services USA:||800-366-5288|
|Every effort has been made to ensure the accuracy of the Domoso Gel information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.|
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