QUALITY CHOICE ANTIFUNGAL- tolnaftate ointment 
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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QC Anti-Fungal Cream 1 oz Tolnaftate 97529 (2019)

Active ingredient Purpose

Tolnaftate 1%............................................................Antifungal

Uses

Warnings

For external use only

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

When using this product, avoid contact with the eyes.

Stop use and ask a doctor if

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

cetostearyl alcohol, ethylparaben, glycerin, glyceryl monostearate, petrolatum, propylene glycol, purified water, sodium sulfite, steareth-20, stearic acid

Distributed by C.D.M.A., Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Made in China

97529

QUALITY CHOICE ANTIFUNGAL 
tolnaftate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-529
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TOLNAFTATE (UNII: 06KB629TKV) (TOLNAFTATE - UNII:06KB629TKV) TOLNAFTATE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
STEARETH-20 (UNII: L0Q8IK9E08)  
ETHYLPARABEN (UNII: 14255EXE39)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
GLYCERIN (UNII: PDC6A3C0OX)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
SODIUM SULFITE (UNII: VTK01UQK3G)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-529-281 in 1 CARTON07/05/2019
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C07/05/2019
Labeler - Chain Drug Marketing Association Inc. (011920774)

Revised: 12/2019
Document Id: 995efd06-8868-421a-e053-2a95a90af8bb
Set id: 8cf73457-d4b2-5401-e053-2a95a90aefc5
Version: 2
Effective Time: 20191210
 
Chain Drug Marketing Association Inc.