AFTATE ATHLETE FOOT CREAM- tolnaftate cream 
Sabel Med LLC

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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Aftate-Tolnaftate Athlete's Foot Cream- 1 oz and 0.5 oz

Active Ingredient-USA

tolnaftate dosage directions USA

tolnaftate inactive USA

tolnaftate warnings USA

Tolnaftate keep out of reach

tolnaftate purpose USA

tolnaftate usage USA

tolnaftate pdp USA

AFTATE ATHLETE FOOT CREAM 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70356-001
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
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
MINERAL OIL (UNII: T5L8T28FGP)  
PROPYLENE GLYCOL 1-(2-METHYLBUTYRATE) (UNII: 9Q5W5G6461)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CHLOROCRESOL (UNII: 36W53O7109)  
CETETH-20 (UNII: I835H2IHHX)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70356-001-0128 g in 1 TUBE; Type 0: Not a Combination Product12/02/2016
2NDC:70356-001-0514 g in 1 TUBE; Type 0: Not a Combination Product12/02/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C12/01/2016
Labeler - Sabel Med LLC (091476000)

Revised: 11/2016
Document Id: 42b2fcc6-ec9f-543f-e054-00144ff8d46c
Set id: 2aa58a66-e00b-74c9-e054-00144ff88e88
Version: 2
Effective Time: 20161123
 
Sabel Med LLC