MAJOR CLOTRIMAZOLE- clotrimazole cream 
Major Pharmaceuticals

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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Drug Facts

Active ingredient

Clotrimazole USP 1% w/w

Purpose

Antifungal Cream

Uses

Cures athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis). Relieves the itching, irritation, redness, scaling and discomfort which can accompany these conditions.

Warnings

  • Do not use on children under 2 years of age unless directed by a doctor.
  • For external use only.
  • Avoid contact with eyes.
  • If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch), discontinue use and consult a doctor.

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

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

aloe vera, benzyl alcohol, cetearyl alcohol, 2-octyldodecanol, polysorbate 60, sorbitan monostearate, spermwax, vitamin E, water

Questions?

Adverse Drug Event call (800)616-2471
Dist. By MAJOR PHARMACEUTICALS
31778 Enterprise Drive, Livonia, Ml 48150 USA
Re-Oder No. 100431

Principal Display Panel – 1 oz. Tube

MAJOR® NDC 0904-7822-31

CLOTRIMAZOLE ANTI-FUNGAL CREAM

CREAM USP, 1%

Cures Most Athlete's Foot NET WT. 28.35 g (1 oz)


Principal Display Panel – 1 oz. Tube

Principal Display Panel – 1 oz. Carton

MAJOR® NDC 0904-7822-31

Cures Most

Athlete's Foot

Relieves Itching, Burning, Greaseless, Nonstaining

CLOTRIMAZOLE ANTI-FUNGAL CREAM

CREAM USP, 1%

*Compare To the active ingredient in Lotrimin-AF® NET WT. 28.35 g (1 oz)

Principal Display Panel – 1 oz. Carton

MAJOR CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7822
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
WATER (UNII: 059QF0KO0R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
CETYL PALMITATE (UNII: 5ZA2S6B08X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0904-7822-311 in 1 CARTON10/04/2004
128.35 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0904-7822-361 in 1 CARTON10/04/2004
214.17 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/04/2004
Labeler - Major Pharmaceuticals (191427277)

Revised: 1/2021
Document Id: 9ee50c01-df42-42b6-9c36-a20b3f61504d
Set id: 7aa3e2eb-64c0-4585-8b80-7dc96c36fc1f
Version: 3
Effective Time: 20210113
 
Major Pharmaceuticals