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Tineacide Physician Formula by Blaine Labs Inc.

Dosage form: cream
Ingredients: UNDECYLENIC ACID 13g in 100g
Labeler: Blaine Labs Inc.
NDC Code: 65373-100

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active IngredientsUndecylenic Acid

Inactive Ingredients

Aloe Vera, Cetyl Alcohol, Clotrimazole, Coco-Caprylate Caprate, Disodium EDTA, Glyceryl Stearate, Hydroxyethylcellulose, Lavender Oil, Methylparaben, PEG-100, Stearate, Polysorbate 60, Propylparaben, Stearic Acid, Tea Tree Oil, Triethanolamine, Urea, Water

Uses

Cures Athlete's Foot (tinea pedis) jock itch (tinea cruris) and ringworm (tinea corporis).

Uses For effective relief of itching, cracking, burning and discomfort which can accompany these conditions.

Ask Your PhysicianDo not use on children under 2 years of age unless directed by a physician

When Using This Product

Wash the affected area with soap and water and dry thoroughly.  Apply sparingly over affected area twice daily (morning and night) or as directed by a physician.  For athlete's foot pay special attention to spaces between the toes.  wear well-fitting ventilated shoes and change shoes and socks at least once daily.  For athlete's foot and ringworm use daily for 4 weeks.  for jock itch use daily for 2 weeks.  If condition persists longer, consult a physician.

Warnings

For external use only.  Avoid contact with eyes.  If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch) discontinue use and consult a physician.  Keep this and all drugs out of the reach of children.  In case of accidental ingestion seek professional assistance or contact a poison control center immediately.

Tineacide LabelTineacide Antifungal Cream  Physician Formula
Dispensed by a physician only.




TINEACIDE PHYSICIAN FORMULA 
undecylenic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65373-100
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID13 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CETYL ALCOHOL 
ALOE VERA LEAF 
CLOTRIMAZOLE 
EDETATE DISODIUM 
GLYCERYL MONOSTEARATE 
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) 
ENGLISH LAVENDER OIL 
METHYLPARABEN 
POLYOXYL 100 STEARATE 
POLYSORBATE 60 
PROPYLPARABEN 
STEARIC ACID 
TEA TREE OIL 
TROLAMINE 
UREA 
Packaging
#Item CodePackage Description
1NDC:65373-100-0135.4 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/1995
TINEACIDE 
undecylenic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65373-500
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CETYL ALCOHOL 
ALOE VERA LEAF 
CLOTRIMAZOLE 
EDETATE DISODIUM 
GLYCERYL MONOSTEARATE 
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) 
ENGLISH LAVENDER OIL 
METHYLPARABEN 
POLYOXYL 100 STEARATE 
POLYSORBATE 60 
PROPYLPARABEN 
STEARIC ACID 
TEA TREE OIL 
TROLAMINE 
UREA 
Packaging
#Item CodePackage Description
1NDC:65373-500-0135.4 g in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/1995
Labeler - Blaine Labs Inc. (017314571)
Registrant - Blaine Labs Inc. (017314571)
Establishment
NameAddressID/FEIOperations
Blaine Labs Inc.017314571manufacture

Revised: 01/2011
 
Blaine Labs Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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