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Athletes Foot by Blaine Labs Inc.

Medically reviewed on April 2, 2018

Dosage form: cream
Ingredients: UNDECYLENIC ACID 14.77mg in 59.148mL
Labeler: Blaine Labs Inc.
NDC Code: 63347-205

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.

Athletes Foot - 205

DRUG FACTS
Active Ingredient

Undecylenic Acid 25%

Purpose

Antifungal

Keep out of reach of children

Keep this and all drugs out of reach of children. In case of accidential ingestion, seek professional assistance, or contact aa poison control center immediately.

INDICATIONS:

Cures Althete's Foot (Tinea Pedis), Jock Itch (Tinea Cruris) and Ringworm (Tinea Corporis). For effective relief of itching, cracking, burning, and discomfort, which can accompany these conditions.

WARNINGS:

Do not use on children under two years of age unless directed by a physician. For external use only. Avoid contact with eyes. If irritation occurs or if there is no improvement within four (4) weeks (for Athlete's Foot or Ringworm) or within two (2) weeks (for Jock Itch), discontinue use and consult a physician.  

DIRECTIONS:

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 attentionto 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 four (4) weeks. For Jock Itch, use daily for two (2) weeks. If condition persists longer, consult a physician.

INACTIVE INGREDIENTS:

Water, Hydroxyenthylcellulose, Aloe Barbadensis (Aloe) Leaf Juice, Urea, Disodium EDTA, Coco Caprylate/Caprate, Polysorbate 60, PEG-100 Stearate, Cetyl Alcohol, Glyceryl Stearate, Stearic Acid, Methylparaben, Propylparaben, Sodium Polyacrylate, Hydrogenated Polydecene, Ultramarines, Menthol, Oregano Oil, Peppermint Oil, Triethanolamine

Athlete's Foot Cream product label

NDC: 63347-205-01

Athlete's Foot Cream

PRACTICE EXCLUSIVE


Undecylenic Acid 25%

Jojoba Bead technology

2.0 FL OZ

Manufactured by: Blaine Labs, Inc., 11037

Lockport Place, Santa Fe Springs, CA 90670

ATHLETES FOOT 
undecylenic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63347-205
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNDECYLENIC ACID) UNDECYLENIC ACID14.77 mg  in 59.148 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) 
ALOE VERA LEAF 
UREA 
EDETATE DISODIUM 
COCO-CAPRYLATE/CAPRATE 
POLYSORBATE 60 
PEG-100 STEARATE 
CETYL ALCOHOL 
GLYCERYL MONOSTEARATE 
STEARIC ACID 
METHYLPARABEN 
PROPYLPARABEN 
SODIUM POLYACRYLATE (2500000 MW) 
HYDROGENATED POLYDECENE (550 MW) 
ULTRAMARINE BLUE 
MENTHOL 
OREGANO LEAF OIL 
PEPPERMINT OIL 
TROLAMINE 
Packaging
#Item CodePackage Description
1NDC:63347-205-0159.148 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/01/2016
Labeler - Blaine Labs Inc. (017314571)
Registrant - Blaine Labs Inc. (017314571)
Establishment
NameAddressID/FEIOperations
Blaine Labs Inc.017314571manufacture(63347-205)

 
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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