FAMILY WELLNESS ANTIFUNGAL (CLOTRIMAZOLE) CREAM [FAMILY DOLLAR]

FAMILY WELLNESS ANTIFUNGAL (CLOTRIMAZOLE) CREAM [FAMILY DOLLAR]
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NDC 55319-334-14
Set ID 590b3e00-7512-480a-9501-f79e66de5b19
Category HUMAN OTC DRUG LABEL
Packager Family Dollar
Generic Name
Product Class Azole Antifungal
Product Number
Application Number PART333C
  • 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 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 Poision 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 once a day
    • 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 no effective on the scalp or nails
  • STORAGE AND HANDLING

    Other information

    • Store between 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzyl alcohol, cetanol, liquid paraffin, octyldodecanol, polysorbate 60, proylene glycol, purified water, sodium hydroxide, sorbitan monostearate, stearic acid, stearyl alcohol

  • QUESTIONS

    Questions or comments?

    Call 1-800-814-8028 Mon-Fri 9AM-5PM

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY: MIDWOOD BRANDS, LLC

    10611 MONROE RD., MATTHEWS, NC 28105

    MADE IN SOUTH KOREA

  • PRINCIPAL DISPLAY PANEL

    454

  • INGREDIENTS AND APPEARANCE
    FAMILY WELLNESS ANTIFUNGAL 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-334
    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
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-334-141 in 1 BOX11/08/2016
    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 finalpart333C01/20/2014
    Labeler - Family Dollar (024472631)

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