TINAACIDE 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.

----------

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

Blaine Tineacide1

Blaine Tineacide2

Blaine Tineacide3

res

TINAACIDE ATHLETES FOOT
undecylenic acid cream

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63347-520-01	56.7 g in 1 BOTTLE; Type 0: Not a Combination Product	08/01/2012	12/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	08/01/2012	12/01/2020

Labeler - Blaine Labs Inc. (017314571)

Registrant - Blaine Labs Inc. (017314571)

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

Revised: 12/2020

Document Id: 7ffbc527-f50e-42fd-9cd5-8d1caf5ea53f

Set id: c9d03a52-8696-4965-996b-67c057a4f578

Version: 4

Effective Time: 20201211

Blaine Labs Inc.