TOLNAFTATE CREAM 1%- tolnaftate cream 
Pharmacy Value Alliance, 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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Tolnaftate Cream 1%

Drug Facts

Active Ingredient

Tolnaftate 1%

Purpose

Anti-Fungal

Uses

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Warnings

For External Use Only

When using this product avoid contact with the eyes

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

Directions

Stop use and ask a doctor if

Other Information

Inactive ingredients:

Cetyl alcohol, Ethylparabe, Glycerol, Glyceryl Monostearate, Mineral Oil, Petrolatum, Purified Water, Sodium Dodecyl sulfate

Soothes Itching, Burning and Cracking

Distributed By:

Pharmacy Value Alliance, LLC.

407 East Lancaster Avenue, Wayne, PA. 19087 USA

www.emersongroup.com

Packaging

Anti-Fungal Cream

TOLNAFTATE CREAM 1% 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-152
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
WATER (UNII: 059QF0KO0R)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PETROLATUM (UNII: 4T6H12BN9U)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-152-011 in 1 BOX08/31/2016
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C08/23/2016
Labeler - Pharmacy Value Alliance, LLC. (101668460)
Registrant - Trifecta Pharmaceuticals USA, LLC. (079424163)

Revised: 5/2023
Document Id: fb451364-d1ff-a7f6-e053-6394a90a5de9
Set id: 3abfd734-229b-1a0e-e054-00144ff88e88
Version: 4
Effective Time: 20230509
 
Pharmacy Value Alliance, LLC.