Salkera Foam

Generic Name: salicylic acid
Dosage Form: aerosol, foam

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.


Salkera
Topical aid in the removal of excessive keratin in hyperkeratotic skin disorders.

Salkera Foam Description

SALKERA® Emollient Foam is a keratolytic that contains 6% salicylic acid USP incorporated into an aqueous based emollient foam vehicle. Each gram of SALKERA Emollient Foam contains 6% w/w salicylic acid USP, aloe, ammonium lactate, ceteth-10 phosphate, ceteth-20 phosphate, cetostearyl alcohol NF, dicetyl phosphate, dl alpha tocopheryl acetate USP, edetate disodium dihydrate USP, glycerin USP, methylparaben NF, propylene glycol USP, propylparaben NF, purified water USP, sodium hydroxide NF, white petrolatum USP.

Also contains: Propellant HFA-134a (1,1,1,2-tetrafluoroethane).

Salicylic Acid USP is the 2-hydroxy derivative of benzoic acid having the following structure:

Salkera Foam - Clinical Pharmacology

Salicylic acid has been shown to produce desquamation of the horny layer of skin while not effecting qualitative or quantitative changes in the structure of the viable epidermis.1,2 The mechanism of action has been attributed to a dissolution of intercellular cement substance.3 In a study of the percutaneous absorption of salicylic acid in a 6% salicylic acid gel in four patients with extensive active psoriasis, Taylor and Halprin4 showed that the peak serum salicylate levels never exceeded 5 mg/100 ml even though more than 60% of the applied salicylic acid was absorbed. Systemic toxic reactions are usually associated with much higher serum levels (30 to 40 mg/100 ml). Peak serum levels occurred within five hours of the topical application under occlusion. The sites were occluded for 10 hours over the entire body surface below the neck. Since salicylates are distributed in the extracellular space, patients with a contracted extracellular space due to dehydration or diuretics have higher salicylate levels than those with a normal extracellular space.5 (See PRECAUTIONS.)

The major metabolites identified in the urine after topical administration are salicyluric acid (52%), salicylate glucuronides (42%) and free salicylic acid (6%).4 The urinary metabolites after percutaneous absorption differ from those after oral salicylate administration; those derived from percutaneous absorption contain more salicylate glucuronides and less salicyluric and salicylic acid. Almost 95% of a single dose of salicylate is excreted within 24 hours of its entrance into the extracellular space.5

Fifty to eighty percent of salicylate is protein bound to albumin. Salicylates compete with the binding of several drugs and can modify the action of these drugs; by similar competitive mechanisms other drugs can influence the serum levels of salicylate.5 (See PRECAUTIONS.)

Indications and Usage for Salkera Foam

For Dermatologic Use: SALKERA Emollient Foam is a topical aid in the removal of excessive keratin in hyperkeratotic skin disorders, including verrucae, and the various ichthyoses (vulgaris, sex-linked and lamellar), keratosis palmaris and plantaris, keratosis pilaris, pityriasis rubra pilaris, and psoriasis (including body, scalp, palms and soles).
For Podiatric Use: SALKERA Emollient Foam is a topical aid in the removal of excessive keratin on dorsal and plantar hyperkeratotic lesions. Topical preparations of 6% salicylic  acid have been reported to be useful adjunctive therapy for verrucae plantares.

Contraindications

SALKERA Emollient Foam should not be used in any patient known to be sensitive to salicylic acid or any other listed ingredient. SALKERA Emollient Foam should not be used in children under 2 years of age.

Warnings

Prolonged and repeated daily use over large areas, especially in children and those patients with significant renal or hepatic impairment, could result in salicylism. Excessive application of the product other than is needed to cover the affected area will not result in a more rapid therapeutic benefit. Concomitant use of other drugs which may contribute to elevated serum salicylate levels should be avoided where the potential for toxicity is present. In children under 12 years of age and those patients with renal or hepatic impairment, the area to be treated should be limited and the patient monitored closely for signs of salicylate toxicity: nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea, diarrhea, and psychic disturbances. In the event of salicylic acid toxicity, the use of SALKERA Emollient Foam should be discontinued. Fluids should be administered to promote urinary excretion. Treatment with sodium bicarbonate (oral or intravenous) should be instituted as appropriate. Patients should be cautioned against the use of oral aspirin and other salicylate containing medications, such as sports injury creams, to avoid additional excessive exposure to salicylic acid. Where needed, aspirin should be replaced by an alternative non-steroidal anti-inflammatory agent that is not salicylate based.

Due to potential risk of developing Reye's syndrome, salicylate products should not be used in children and teenagers with varicella or influenza, unless directed by a physician.

Keep out of the reach of children. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120ºF (49ºC).

Precautions

For EXTERNAL USE ONLY. Avoid contact with eyes and other mucous membranes. Mild burning or stinging may occur. Peeling of the skin may increase as the salicylic acid works to loosen excess keratin. If excessive burning, stinging or peeling occurs, discontinue use and consult your physician. Keep this and all medications out of reach of children.
FOR DERMATOLOGICAL USE ONLY. NOT FOR OPTHALMIC, ORAL OR INTRAVAGINAL USE.


Drug Interactions

The following interactions are from a published review5 and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of SALKERA Emollient Foam is not known

I. Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur:
DRUG DESCRIPTION OF INTERACTION

Tolbutamide; Sulfonylureas

Hypoglycemia potentiated.

Methotrexate 

Decreases tubular reabsorption; clinical toxicity from methotrexate can result.

Oral Anticoagulants

Increased bleeding.

II. Drugs changing salicylate levels by altering renal tubular reabsorption:

DRUG

DESCRIPTION OF INTERACTION

Corticosteroids

Decreases plasma salicylate level; tapering doses of steroids may promote salicylism.

Acidifying Agents

Increases plasma salicylate level.

Alkanizing Agents

Decreased plasma salicylate levels.

III.Drugs with complicated interactions with salicylates: 

DRUG

DESCRIPTION OF INTERACTION

Heparin 

Salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin treated patients. 

Pyrazinamide

Inhibits pyrazinamide induced hyperuricemia.

Uricosuric Agents

Effect of probenemide, sulfinpyrazone and phenylbutazone inhibited.

LABORATORY TESTS

The following alterations of laboratory tests have been reported during salicylate therapy6:

LABORATORY TESTS

EFFECT OF SALICYLATES 

Thyroid Function 

Decreased PBI; increased T3 uptake

Urinary Sugar

False negative with glucose oxidase; False positive with Clinitest with high-dose salicylate therapy (2-5g q.d.).

5-Hydroxyindole acetic acid      

False negative with fluorometric test.

Acetone ketone bodies 

False positive FeCl3 in Gerhardt reaction; red color persists with boiling. 

17-OH corticosteroids

False reduced values with >4.8g q.d. salicylate. 

Vanilmandelic acid

False reduced values

Uric acid 

May increase or decrease depending on dose. 

Prothrombin 

Decreased levels; slightly increased prothrombin time. 

PREGNANCY (Category C)

Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent six times the maximal daily human dose of salicylic acid when applied topically over a large body surface. There are no adequate and well-controlled studies in pregnant women. SALKERA Emollient Foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

Because of the potential for serious adverse reactions in nursing infants from the mother's use of SALKERA Emollient Foam, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. If used by nursing mothers, it should not be used on the chest area to avoid the accidental contamination of the child.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

No data are available concerning potential carcinogenic or reproductive effects of SALKERA Emollient Foam. Salicylic acid has been shown to lack mutagenic potential in the Ames Salmonella test.

Adverse Reactions

Excessive erythema and scaling conceivably could result from use on open skin lesions.

Overdosage

See Warnings.

Salkera Foam Dosage and Administration

Shake Vigorously, Tap Bottom of Can, and Prime Before Initial Use. Shake Vigorously and Tap Before Each Use.

To Prime: After shaking, gently tap bottom of can onto palm of other hand or a solid surface at least 3 times. Hold the can upright, direct away from the patient, and firmly depress the actuator for 1 to 3 seconds or until foam begins to dispense. (If foam does not dispense within 3 seconds: reshake can, gently tap bottom of can onto a solid surface at least 3 times, and depress the actuator again until foam begins to dispense.) Before Each Use: Shake vigorously and gently tap bottom of can onto palm of other hand or a solid surface at least 3 times. During Use: Holding can upright, dispense SALKERA into palm of hand and apply thoroughly to affected area twice per day, or as directed by a physician. Rub in completely. Wipe off any excess foam from actuator after use. The preferable method of use is to apply SALKERA thoroughly to the affected area and to cover the treated area at night, after washing and before retiring. Preferably, the skin should be hydrated for at least five minutes prior to application. The medication is washed off in the morning and if excessive drying and/or irritation is observed a bland cream or lotion may be applied. Once clearing is apparent, the occasional use of SALKERA Emollient Foam will usually maintain the remission. In those areas where the placement of a protective covering is difficult or impossible, application of SALKERA Emollient Foam may be made more frequently; hydration by wet packs or baths prior to application apparently enhances the effect. (See WARNINGS.) Unless hands are being treated, hands should be rinsed thoroughly after application. Excessive repeated application of SALKERA Emollient Foam will not necessarily increase its therapeutic benefit, but could result in increased local intolerance and systemic adverse effects such as salicylism.

How is Salkera Foam Supplied

SALKERA Emollient Foam is supplied in 60g (NDC# 16781-167-60) and 100g (NDC#16781-167-96) aluminum cans.

Store at room temperature 59º - 77ºF (15º - 25ºC) Protect from freezing Store upright.


Manufactured for:

Onset Therapeutics
Cumberland, RI 02864

www.onsettx.com
(888) 713-8154

Patent Pending
P/N 2605 Rev. 2

Rx Only

FOR DERMATOLOGICAL USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.


REFERENCES

1. Davies M, Marks R: Br J Dermatol 95: 187-192, 1976.

2. Marks R, Davies M, Cattel A: J Invest Dermatol 64: 283, 1975.

3. Huber C, Christophers E: Arch DermRes 257: 293-297, 1977.

4. Taylor JR, Halprin KM: Arch Dermatol 111: 740-743, 1975.

5. Goldsmith LA: Int J Dermatol 18: 32-36, 1979.

6. Wilson JG, Ritter EJ, Scott WJ, Fradlein R: Tox Appl Pharmacol 41: 67-78, 1977.

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Salkera 5g Carton:

NDC 16781-167-06
Rx Only

Salkera®
Emollient Foam
Salicylic Acid 6% in an Ammonium Lactate Vehicle

Topical aid in the removal of excessive keratin in hyperkeratotic skin disorders.
See prescribing information enclosed.



PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Salkera 5g Label:

NDC 16781-167-06
Rx Only
Professional Sample
Not for Sale
Net Weight 5 g

Salkera®
Emollient Foam
Salicylic Acid 6% in an Ammonium Lactate Vehicle



PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Salkera 60g Carton:

NDC 16781-167-60
Rx Only

Salkera
Emollient Foam
Salicylic Acid 6%

Topical aid in the removal of excessive keratin in hyperkeratotic skin disorders.

Net Weight 60g



PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Salkera 60g Label:

NDC 16781-167-60
Rx Only

Salkera
Emollient Foam
Salicylic Acid 6%


Net Weight 60g



SALKERA 
salicylic acid aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:16781-167
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 6 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
PROPYLENE GLYCOL  
CETOSTEARYL ALCOHOL  
ALPHA-TOCOPHEROL ACETATE  
METHYLPARABEN  
PROPYLPARABEN  
WATER  
PETROLATUM  
GLYCERIN  
EDETATE DISODIUM  
ALOE  
SODIUM HYDROXIDE  
AMMONIUM LACTATE  
Packaging
# Item Code Package Description
1 NDC:16781-167-06 6 CAN (6 CAN) in 1 BOX
1 5 g in 1.0 CAN
2 NDC:16781-167-11 6 CAN (6 CAN) in 1 BOX
2 10 g in 1.0 CAN
3 NDC:16781-167-60 1 CAN (1 CAN) in 1 BOX
3 60 g in 1.0 CAN
4 NDC:16781-167-96 1 CAN (1 CAN) in 1 BOX
4 100 g in 1.0 CAN
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/2008 12/31/2011
Labeler - Onset Dermatologics LLC (793223707)
Registrant - Onset Dermatologics LLC (964275155)
Establishment
Name Address ID/FEI Operations
Onset Dermatologics LLC 793223707 Manufacture
Revised: 11/2011
 
Onset Dermatologics LLC
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