TOLNAFTATE D- tolnaftate cream 
NexMed (USA), 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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Drug Facts

Active Ingredient

Tolnaftate

Purpose

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

cetyl  alcohol, dodecyl-2-N N-dimethylaminopropionate hydrochloride, methylparaben, mineral oil, ceteth-10, propylene glycol, propylparaben, purified water, sorbitan monostearate, stearyl alcohol

Questions?

Call 858-222-8041, Mon-Fri, 8:30 AM - 5:30PM (PST)

Image of carton label

TOLNAFTATE  D
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40002-002
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
Cetyl Alcohol (UNII: 936JST6JCN)  
Dodecyl-2-N,N-Dimethylaminopropionate Hydrochloride (UNII: 18F5YMF989)  
Methylparaben (UNII: A2I8C7HI9T)  
Mineral Oil (UNII: T5L8T28FGP)  
Ceteth-10 (UNII: LF9X1PN3XJ)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Propylparaben (UNII: Z8IX2SC1OH)  
Water (UNII: 059QF0KO0R)  
Sorbitan Monostearate (UNII: NVZ4I0H58X)  
Stearyl Alcohol (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:40002-002-011 in 1 CARTON
1NDC:40002-002-0228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/15/2011
Labeler - NexMed (USA), Inc. (031710528)
Registrant - NexMed (USA), Inc. (031710528)

Revised: 8/2011
Document Id: 331f6703-c665-4168-ae6b-4e38d58905f9
Set id: a09029b2-942e-479d-aa21-453d9a03f60e
Version: 4
Effective Time: 20110816
 
NexMed (USA), Inc.