THERA PLUS ANTIFUNGAL CLOTRIMAZOLE- clotrimazole cream 
FOURSTAR GROUP USA, INC.

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Thera plus Antifungal Clotrimazole cream

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 except under the advice of 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 within 2 weeks (for jock itch).

If pregnant or breast-feeding,

ask a health professional before use

Keep this and all drugs out of the reach of children.

if swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

Inactive ingredients

cetostearyl alcohol, ethylparaben, glycerin, glyceryl monostearate, mineral oil, peregal O-25, petrolatum, purified water, stearic acid

Questions or comments?

Call 1-888-296-9067 Mon-Fri 9 AM-5 PM

Package Labeling:

Outer PackageInner Package

THERA PLUS ANTIFUNGAL CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80684-039
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
LAURETH-23 (UNII: N72LMW566G)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ETHYLPARABEN (UNII: 14255EXE39)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80684-039-011 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: 08a0ce90-0c11-15f4-e063-6294a90a6ca7
Set id: 1265be99-8922-4b76-bd63-19bfb42c3896
Version: 2
Effective Time: 20231026
 
FOURSTAR GROUP USA, INC.