TOLNAFTATE- tolnaftate cream 
Sheffield Pharmaceuticals LLC

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Drug Facts

Active ingredient

Tolnaftate USP 1%

Purpose

Antifungal Cream

Uses

Warnings

Keep this and all drugs out of the reach of children.In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

For athlete's foot

Other information

Inactive ingredients

Ceteth-20, Cetostearyl Alcohol, Chlorocresol, Mineral Oil, White Petrolatum, Propylene Glycol, Sodium Phosphate Monobasic, Water

Questions?

1-800-222-1087

Principal Display Panel – 1.25 oz Tube

Dr. Sheffield's NDC 11527-051-40

Antifungal Cream (Tolnaftate 1%) Made in the USA

CURES Most:

ATHLETE'S

FOOTJOCK ITCH

RINGWORM                                 Net Wt. 1.25 OZ (35.4 g)

Principal Display Panel – 1.25 oz Tube

Principal Display Panel – 1.25 oz Tube

Principal Display Panel – 1.25 oz Carton

Principal Display Panel – 1.25 oz Carton

Dr. Sheffield's NDC 11527-051-40

CURES Most:

ATHLETE'S

FOOTJOCK ITCH

RINGWORM                                               Net Wt. 1.25 OZ (35.4 g)

Principal Display Panel – 1.25 oz Carton

TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-051
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
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
CHLOROCRESOL (UNII: 36W53O7109)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11527-051-401 in 1 CARTON10/07/2009
135.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:11527-051-511 in 1 CARTON10/07/2009
214 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00510/07/2009
Labeler - Sheffield Pharmaceuticals LLC (151177797)
Registrant - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797MANUFACTURE(11527-051) , analysis(11527-051)

Revised: 11/2023
Document Id: aafc94b4-c410-4bdd-954c-861835e044ce
Set id: ca52af37-c3a2-414c-a24a-a37a92925133
Version: 4
Effective Time: 20231120
 
Sheffield Pharmaceuticals LLC