ANTIFUNGAL- tolnaftate 1% cream 
Chain Drug Marketing Association 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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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 product avoid 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.

43157 W 9 Mile Road

Novi, MI. 48375

www.qualitychoice.com

Questions: 800-935-2362

Product of PRC

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

antifungal cream tolnaftate 1oz

ANTIFUNGAL 
tolnaftate 1% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-685
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:63868-685-011 in 1 BOX08/14/2020
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 finalpart333C08/14/2020
Labeler - Chain Drug Marketing Association Inc. (011920774)
Registrant - Trifecta Pharmaceuticals USA, LLC. (079424163)

Revised: 5/2023
Document Id: fc5f2212-8ecb-e4c8-e053-6394a90a7483
Set id: acdbebf1-319d-dfe9-e053-2995a90ad430
Version: 3
Effective Time: 20230523
 
Chain Drug Marketing Association Inc.