ATHLETES FOOT- undecylenic acid cream 
Blaine Labs Inc.

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.

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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

Blaine AthletesFoot 205

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ATHLETES FOOT 
undecylenic acid cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63347-205
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N) UNDECYLENIC ACID14.77 mg  in 59.148 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
UREA (UNII: 8W8T17847W)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
MENTHOL (UNII: L7T10EIP3A)  
OREGANO LEAF OIL (UNII: 7D0CGR40U1)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63347-205-0159.148 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2016
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)

Revised: 2/2022
Document Id: 515b2973-9b43-49bb-aefd-a92a780d1b75
Set id: 9c66686b-3664-4413-b49e-3ed067bcd4e4
Version: 4
Effective Time: 20220218
 
Blaine Labs Inc.