ATHLETES FOOT- undecylenic acid cream

Athletes Foot by

Drug Labeling and Warnings

Athletes Foot by is a Otc medication manufactured, distributed, or labeled by Blaine Labs Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTSActive 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

INGREDIENTS AND APPEARANCE

ATHLETES FOOT 
undecylenic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63347-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	14.77 mg  in 59.148 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63347-205-01	59.148 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/01/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	04/01/2016

Labeler - Blaine Labs Inc. (017314571)

Registrant - Blaine Labs Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc.		017314571	manufacture(63347-205)