ASTONEA ANTIFUNGAL CREAM TOLNAFLATE- tolnaftate cream 
ASTONEA LABS PRIVATE LIMITED

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ASTONEA Antifungal Cream TOLNAFLATE

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

Warnings

For external use only

Do not use on children under 2 years of age unless directed by a doctor

When using this productavoid 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 right away. (1-800-222-1222)

Directions

adults and children 2 years of age and over:

Children under 2 years of age: consult a physician

Other information

store between 20° to 25°C (68° to 77°F)

Inactive ingredients

ceteth-20, cetostearyl alcohol, chlorocresol, edetate disodium, light mineral oil, petrolatum, propylene glycol, sodium metabisulfite, water

Questions?

Toll Free 1-866-326-1313

PRINCIPAL DISPLAY PANEL - 35.4 g Tube Carton

Principal Display and Drug Fact Panel

ASTONEA ANTIFUNGAL CREAM TOLNAFLATE 
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-934
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
PETROLATUM (UNII: 4T6H12BN9U)  
CETETH-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CHLOROCRESOL (UNII: 36W53O7109)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
SODIUM PHOSPHATE, DIBASIC, MONOHYDRATE (UNII: BWZ7K44R51)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-934-011 in 1 CARTON03/05/2024
135.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00503/05/2024
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 3/2024
Document Id: 12efc4ba-025b-eb55-e063-6294a90a9c3e
Set id: 12efcacd-2066-f25c-e063-6294a90a4dc0
Version: 1
Effective Time: 20240305
 
ASTONEA LABS PRIVATE LIMITED