QUALITY CHOICE TOLNAFTATE ANTIFUNGAL- tolnaftate 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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QC Anti-Fungal Cream 1oz NBE Tinactin

Active ingredient                                                                  Purpose

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

Uses

Warnings For external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients propylene glycol, liquid paraffin, stearyl alcohol, cetyl alcohol, sorbitan monostearate, polyoxyethylene cetylether, purified water, methylparaben, propylparaben

Distributed By Quality Choice

Novi, Mi 48376-0995

Made in Korea

image description

QUALITY CHOICE TOLNAFTATE ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-104
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
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
MINERAL OIL (UNII: T5L8T28FGP)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-104-461 in 1 CARTON05/31/2013
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C05/31/2013
Labeler - Chain Drug Marketing Association Inc (011920774)

Revised: 12/2017
Document Id: 602ee07d-770e-4328-e053-2991aa0ad96b
Set id: 684e9447-e16e-42e2-b268-e37b48eb2e92
Version: 5
Effective Time: 20171212
 
Chain Drug Marketing Association Inc