GADADERM ANTIFUNGAL- tolnaftate cream 
Gadal Laboratories 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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Active Ingredient                                   Purpose

Tolnaftate 1%                                       Antifungal

Purpose

Antifungal

Uses

Warnings: For External Use Only.

Do not use on children under 2 years of age unless directed by a doctor.

When using this product avoid contact with the eyes.

Stop use and ask a doctor if

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

Directions

Inactive ingredients Mineral oil, propylene glycol, cety stearyl alcohol, purified water, ceteareth-6, stearyl alcohol, PEG-20 cetyl/stearyl ether, methylparaben, sodium m-bisulfite, propylparaben

SSS Group LLC.

Miami, Fl 33186

tolnaftate

GADADERM ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53113-263
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)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
WATER (UNII: 059QF0KO0R)  
CETEARETH-6 (UNII: 2RJS3559D3)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM BISULFITE (UNII: TZX5469Z6I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53113-263-011 in 1 BOX
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C01/01/2013
Labeler - Gadal Laboratories Inc (841305639)

Revised: 9/2013
Document Id: 6636e999-6ece-4cab-8f36-1feb1802e9d1
Set id: 3a798e01-e531-4d11-a388-cee3d1006b57
Version: 1
Effective Time: 20130927
 
Gadal Laboratories Inc