Label: FAMILY WELLNESS CLOTRIMAZOLE 1 ANTI FUNGAL CREAM- clotrimazole cream

  • NDC Code(s): 55319-980-00
  • Packager: Family Dollar Stores, Inc
  • 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 August 18, 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 info rmation

    • 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 1-800-639-3803Weekdays 9 AM to 4 PM EST

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS CLOTRIMAZOLE 1 ANTI FUNGAL CREAM 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-980
    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
    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:55319-980-001 in 1 BOX01/01/2024
    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 finalpart333C01/01/2024
    Labeler - Family Dollar Stores, Inc (024472631)
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