THERA PLUS ANTIFUNGAL TOLNAFTATE- tolnaftate cream 
FOURSTAR GROUP USA, INC.

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Thera plus Antifungal Tolnaftate cream

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Anti-Fungal

Uses

Warnings

For external use only.

Do not use

on children under 2 years of age except under the advice and supervision of a doctor.

When using this product

avoid contact with the eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks.

Keep out of reach of children.

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

Directions

Other information

Inactive ingredients

cetyl alcohol, ethylparaben, glycerol, glyceryl monostearate, mineral oil, petrolatum, purified water, sodium lauryl sulfate

Questions?

1-888-296-9067 Weekdays 9 AM to 4 PM EST

Package Labeling:

Outer Package2Inner Package2

THERA PLUS ANTIFUNGAL TOLNAFTATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80684-040
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
CETYL ALCOHOL (UNII: 936JST6JCN)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80684-040-011 in 1 BOX01/30/2022
114 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00501/30/2022
Labeler - FOURSTAR GROUP USA, INC. (140099503)

Revised: 10/2023
Document Id: 08a0d819-d9c5-15e9-e063-6294a90acb44
Set id: c628dda8-7a6d-5f3a-e053-2995a90a35f8
Version: 2
Effective Time: 20231026
 
FOURSTAR GROUP USA, INC.