Label: THERA PLUS ANTIFUNGAL CLOTRIMAZOLE- clotrimazole cream

  • NDC Code(s): 80684-039-01
  • Packager: FOURSTAR GROUP USA, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 26, 2023

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  • Drug Facts

  • Active ingredient

    Clotrimazole 1% w/w

    Purpose

    Antifungal

  • Uses

    • cures most athlete’s foot, jock itch, and ringworm
    • relieves itching, burning, cracking, scaling and discomfort which can accompany these conditions.
  • 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

    • wash the affected area and dry thoroughly.
    • apply a thin layer over affected area twice daily (morning and night)
    • 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 room temperature 20°-25°C (68°-77°F).
    • close cap tightly after use.
  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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