ASTONEA CLOTRIMAZOLE 1% ATHLETES FOOT- clotrimazole cream 
ASTONEA LABS PRIVATE LIMITED

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Astonea Clotrimazole USP, 1%

Drug Facts

Active ingredient

Clotrimazole 1% (w/w)

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 product

  • avoid contact with eyes.

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

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

Directions

Other information

Inactive ingredients

Ceteth-20, Cetostearyl Alcohol, Chorocresol, Edetate Disodium, Light Mineral Oil, Propylene Glycol, Sodium Metabisulfite,Water

Principal Display Panel

Principal Display and Drug Fact Panel

ASTONEA CLOTRIMAZOLE 1%  ATHLETES FOOT
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77338-312
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
CETETH-20 (UNII: I835H2IHHX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
WATER (UNII: 059QF0KO0R)  
CHLOROCRESOL (UNII: 36W53O7109)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77338-312-4428.3 g in 1 TUBE; Type 0: Not a Combination Product03/04/2020
2NDC:77338-312-48113 g in 1 TUBE; Type 0: Not a Combination Product03/04/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00503/04/2020
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 6/2024
Document Id: 1bbb0211-ebfc-bdeb-e063-6294a90af56a
Set id: e5d2b45a-26f2-14a9-e053-2a95a90a2456
Version: 3
Effective Time: 20240625
 
ASTONEA LABS PRIVATE LIMITED