Label: MAJOR CLOTRIMAZOLE- clotrimazole cream

  • NDC Code(s): 0904-7822-31, 0904-7822-36
  • Packager: Major Pharmaceuticals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 Label Information

Updated January 13, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    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. 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

  • INGREDIENTS AND APPEARANCE
    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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!