SIGNATURE CARE ANTIFUNGAL (CLOTRIMAZOLE) CREAM [BETTER LIVING BRANDS LLC]

SIGNATURE CARE ANTIFUNGAL (CLOTRIMAZOLE) CREAM [BETTER LIVING BRANDS LLC]
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NDC 21130-806-15
Set ID b4d9cde8-bf6d-470b-9b5c-29f8e680157e
Category HUMAN OTC DRUG LABEL
Packager Better Living Brands LLC
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

    For external use only

  • DO NOT USE

    Do not use on children under 2 years of age unless directed by a doctor.

  • WHEN USING

    When using this product avoid contact with the eyes.

  • ASK DOCTOR

    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)

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • 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 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

    - store at 20°C to 25°C (68°F to 77°F) - Lot No. & Exp. Date: see box or see crimp of tube

  • INACTIVE INGREDIENT

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

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    BETTER LIVING BRANS LLC

    P.O. BOX 99

    PLEASANTON, CA 94566-0009

    1-888-723-3929

    www.betterlivingbrandsLLC.com

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    SIGNATURE CARE ANTIFUNGAL 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21130-806
    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
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21130-806-151 in 1 CARTON08/26/2015
    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 finalpart333C08/26/2015
    Labeler - Better Living Brands LLC (009137209)

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