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

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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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 finalpart333C03/04/2020
Labeler - ASTONEA LABS PRIVATE LIMITED (878533295)

Revised: 8/2022
Document Id: e673adba-8dd2-6610-e053-2a95a90a2f50
Set id: e5d2b45a-26f2-14a9-e053-2a95a90a2456
Version: 2
Effective Time: 20220817
 
ASTONEA LABS PRIVATE LIMITED