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Major Clotrimazole by REMEDYREPACK INC.

Medically reviewed on February 8, 2017

Dosage form: cream
Ingredients: CLOTRIMAZOLE 10mg in 1g
Labeler: REMEDYREPACK INC.
NDC Code: 70518-0207

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

DRUG: Major Clotrimazole

GENERIC: CLOTRIMAZOLE

DOSAGE: CREAM

ADMINSTRATION: TOPICAL

NDC: 70518-0207-0

PACKAGING: 1 in 1 CARTON

ACTIVE INGREDIENT(S):

  • CLOTRIMAZOLE 10mg in 1g

INACTIVE INGREDIENT(S):

  • .ALPHA.-TOCOPHEROL ACETATE
  • ALOE VERA LEAF
  • CETYL PALMITATE
  • OCTYLDODECANOL
  • SORBITAN MONOSTEARATE
  • BENZYL ALCOHOL
  • CETOSTEARYL ALCOHOL
  • POLYSORBATE 60
  • WATER

MAJOR CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0207(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:70518-0207-014.17 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C02/08/2017
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK INC.

← See all Major Clotrimazole brands

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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