Label: EQUALINE ANTIFUNGAL CREAM- clotrimazole cream

  • 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 March 31, 2022

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  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Clotrimazole 1%..............................Antifungal

  • PURPOSE

    Uses

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

    Warnings

    For external use only

  • DO NOT USE

    Do not use on children under 2 years of age except under the advice and supervision of a doctor.

  • WHEN USING

    When using this product, avoid contact with the eyes.

  • STOP USE

    Stop use and ask a doctor if

    • irritation occurs
    • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • wash 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 spaces between the toes; wear well-fitting, ventilated shoes and change shoes and socks at least one daily
    • for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
    • if condition persists longer, ask a doctor
    • this product is not effective on the scalp or nails
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    cetosteryl alcohol, ethylparaben, glycerin, light mineral oil, propylene glycol, purified water, sodium sulfite, steareth-20,stearic acid

  • DOSAGE & ADMINISTRATION

    Distributed by:

    UNFI

    Providence, RI 02908 USA

    Made in China

  • PRINCIPAL DISPLAY PANEL

    26369

  • INGREDIENTS AND APPEARANCE
    EQUALINE ANTIFUNGAL CREAM 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41163-963
    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)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARETH-20 (UNII: L0Q8IK9E08)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41163-963-141 in 1 CARTON10/06/2020
    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 finalpart333C10/06/2020
    Labeler - SUPERVALU INC (006961411)
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