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Major Clotrimazole by Major Pharmaceuticals

Medically reviewed on July 2, 2018

Dosage form: cream
Ingredients: CLOTRIMAZOLE 10mg in 1g
Labeler: Major Pharmaceuticals
NDC Code: 0904-7822

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.

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
  • Clean the affected area and dry thoroughly.
  • Apply a thin layer of this product over affected area twice daily (morning and night), or as directed by a doctor.
  • Supervise children in the use of this product.
  • For athlete's foot, pay special attention to the spaces between the toes; wear well-fitting ventilated shoes, and change shoes and socks at least once daily.
  • For athlete's foot and ringworm, use daily for 4 weeks. For jock itch, use daily for 2 weeks.
  • If conditions persists longer, consult a doctor.
  • This product is not effective on the scalp or nails.

Other information
  • Store at controlled room temperature 15°-30°C (59°-86°F).
  • Close cap tightly after use.

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. 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)

MAJOR CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-7822
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER 
CETOSTEARYL ALCOHOL 
POLYSORBATE 60 
BENZYL ALCOHOL 
SORBITAN MONOSTEARATE 
.ALPHA.-TOCOPHEROL ACETATE 
ALOE VERA LEAF 
OCTYLDODECANOL 
CETYL PALMITATE 
Packaging
#Item CodePackage Description
1NDC:0904-7822-311 TUBE in 1 CARTON
128.35 g in 1 TUBE
2NDC:0904-7822-361 TUBE in 1 CARTON
214.17 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C10/04/2004
Labeler - Major Pharmaceuticals (191427277)
Registrant - Faria Limited dba Sheffield Pharmaceuticals (151177797)
Establishment
NameAddressID/FEIOperations
Faria LLC dba Sheffield Pharmaceuticals151177797MANUFACTURE(0904-7822)

 
Major Pharmaceuticals

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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