ANTIFUNGAL- tolnaftate 1% cream 
Chain Drug Marketing Association Inc.

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Quality Choice Antifungal Cream Tolnaftate 1%

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Uses

● proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis) ● helps prevent most athlete's foot with daily use ● for effective relief of itching, burning and cracking.

Warnings

For external use only.

When using this productavoid contact with the eyes.

Stop use and ask a doctorl if● irritation occurs ● there is no improvement within 4 weeks improvement

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

Directions

● wash affected area and dry thoroughly

● apply a thin layer over affected area twice daily (morning and night)

● supervise children in the use of this product

● for athlete’s foot: 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 conditions persists longer, ask a doctor.

● to prevent athlete's foot, apply once or twice daily (morning and/or night)

● this product is not effective on the scalp or nails.

Inactive ingredients

Cetyl alcohol, ethylparaben, glycerol, mineral oil, glycerol monostearate, petrolatum, purified water, sodium lauryl sulfate

Other information

● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.

Distributed By

Distributed by CDMA, Inc.

Novi, MI. 48375

www.qualitychoice.com

Questions 800-935-2362

This product is not manufactured or distributed by Bayer Health Care, LLC. distributor of Tinactin® Antifungal Cream.

Label

97529 QC TOLNAFTATE CREAM 1OZ REV06 042624 CDER

ANTIFUNGAL 
tolnaftate 1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83324-049
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83324-049-011 in 1 BOX05/31/2024
128.3 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00508/14/2020
Labeler - Chain Drug Marketing Association Inc. (011920774)
Registrant - Trifecta Pharmaceuticals USA, LLC. (079424163)

Revised: 11/2024
Document Id: 263016ed-0cab-ebba-e063-6394a90a6761
Set id: 26303499-dc58-f417-e063-6394a90a0a1b
Version: 1
Effective Time: 20241105
 
Chain Drug Marketing Association Inc.