TOLNAFTATE CREAM 1% ANTIFUNGAL- tolnaftate cream 
Trifecta Pharmaceuticals Usa 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% ANTIFUNGAL CREAM

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Anti-Fungal

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

Uses

● proven clinically effective in the treatment of most athlete's foot (tinea pedis), and ringworm (tinea corporis) ● helps prevent most athlete's foot with daily use ● for effective relief of itching, burning and cracking.

Warnings

For external use only.

When using this product avoid contact with the eyes.

Stop use and ask a healthcare professional if ● irritation occurs ● there is no improvement within 4 weeks improvement 

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

Directions

● wash affected area and dry thoroughly

● apply a thin layer over affected area twice daily (morning and night)

● supervise children in the use of this product

● for athlete’s foot: pay special attention to spaces between the toes, wear well-fitting ventilated shoes and change shoes and socks at least once daily.

● use daily for 4 weeks; if conditions persists longer, ask a healthcare professional.

● to prevent athlete's foot, apply once or twice daily (morning and/or night)

● this product is not effective on the scalp or nails.

Inactive ingredients

Cetostearyl alcohol, ethylparaben, glycerol, light mineral oil, monostearin, petrolatum, purified water, sodium dodecyl sulfate

Other information

● store between 20° to 25°C ( 68° to 77°F) ● Lot No & Expiration Date: See box or crimp of tube.

100% GUARANTEED

Cures and Prevents Most Athlete's Foot

Distributed by:

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL 33301 USA

Product of PRC


www.trifecta-pharma.com

Packaging

tolnaftate

TOLNAFTATE CREAM 1% ANTIFUNGAL 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69396-016
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
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERIN (UNII: PDC6A3C0OX)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69396-016-201 in 1 BOX04/09/2016
130 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:69396-016-051 in 1 BOX04/09/2016
215 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C04/09/2016
Labeler - Trifecta Pharmaceuticals Usa Llc (079424163)

Revised: 1/2023
Document Id: f276c50b-f4b6-92d8-e053-2a95a90a9b76
Set id: 96a40ccd-17f7-4e4e-98da-207802fa2b2d
Version: 6
Effective Time: 20230117
 
Trifecta Pharmaceuticals Usa Llc