TINAACIDE ATHLETES FOOT- undecylenic acid cream

Tinaacide Athletes Foot by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

INGREDIENTS

Active Ingredients

Undecylenic Acid 25%

Purpose

# 1 TRUSTED BRAND FOR ANTIFUNGALS

Keep Out Of Reach Of Children

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

Use

Athlete's Foot

Warnings

WARNINGS:

Do not use on children under 2 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 4 weeks, discontinue use and consult a physician.

Directions

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. Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least once daily.  Use daily for 4 weeks. If condition persists longer, consult a physician.

Inactive Ingredients

Inactive Ingredients:

Water, Hydroyethylcellulose, Aloe Vera, Disodium EDTA, COCO-Caprylate/Caprate, Polysorbate 60, PEG 100 Stearate, Cetyl Alcohol, Glyceryl Stearate, Stearic Acid, Methylparaben, Propylparaben, Sodium Polyacrylate, Hydrogenated Polydecen, Trideceth-6, Menthol, Oregano Oil, Peppermint Oil, Urea, Triethanolamine, Cosmospheres (Lactose, Microcrystalline Cellulose, Ultramarines, Tocopheryl Acetate

Product Label

Blaine Labs

TINEACIDE

ATHLETE'S FOOT CREAM PHYSICIAN FORMULA

2 fl. oz.

(800) 307-8818   infoBlaineLabs.com   www.BlaineLabs.com   Blaine Labs, Inc. Sante Fe Springs, CA 90670

COLOR SIGNAL TECHNOLOGY

NDC: 63347-520-01   Rev. 20120810

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INGREDIENTS AND APPEARANCE

TINAACIDE ATHLETES FOOT 
undecylenic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63347-520
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UNDECYLENIC ACID (UNII: K3D86KJ24N) (UNDECYLENIC ACID - UNII:K3D86KJ24N)	UNDECYLENIC ACID	25 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
EDETIC ACID (UNII: 9G34HU7RV0)
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)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
MENTHOL (UNII: L7T10EIP3A)
OREGANO LEAF OIL (UNII: 7D0CGR40U1)
PEPPERMINT OIL (UNII: AV092KU4JH)
UREA (UNII: 8W8T17847W)
TROLAMINE (UNII: 9O3K93S3TK)
LACTOSE (UNII: J2B2A4N98G)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
ULTRAMARINE BLUE (UNII: I39WR998BI)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63347-520-01	56.7 g in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	08/01/2012

Labeler - Blaine Labs Inc. (017314571)

Registrant - Blaine Labs Inc. (017314571)

Establishment
Name	Address	ID/FEI	Business Operations
Blaine Labs Inc.		017314571	manufacture(63347-520)