Label: SKIN REPAIR- clotrimazole spray

  • 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 April 27, 2020

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  • DOSAGE & ADMINISTRATION

    30ML, 3-5 sprays each time, twice a day

  • WARNINGS

    For external use only, Do not swallow When using this product
    Keep out of eyes, ears, and mouth. If contact occurs, rinse with plenty of cold water right away and contact a physician. If swallowing, drink plenty of water and contact a physician
    Please consult a doctor, if you have serious wounds, severe burns or animal bites.
    Do not use this product if you are allergic to it.

  • INACTIVE INGREDIENT

    WATER
    METHANOL
    ISOPROPYL ALCOHOL
    N,N-DIMETHYLOCTADECYL AMINE
    PROPYLENE GLYCOL, (S)-
    PROPYLENE CARBONATE

    BENZETHONIUM CHLORIDE

    QUATERNIUM-16

  • ACTIVE INGREDIENT

    CLOTRIMAZOLE

  • INDICATIONS & USAGE

    Hold the spray bottle (do not turn it upside down) withthe spray nozzle 10- 15cm away from the surface of the infectedarea, andspray evenly as far as possible, 3-5 sprays each time, twice a day, andspray on contacting object (if any)once a day. Each dose can be increased or decreased according to the actual situation of the patient. In severe cases, 10-15 sprays are recommended until the acute inflammation or major symptoms disappear.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • PURPOSE

    This product can be used for anti-inflammatory debridement of wounds, and treatment of hair folliculitis, pustule sores, and jock itches caused by bacterial infection. It can also cooperate to treat beriberi, and cut off the source of infection by spraying on shoes and socks.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    SKIN REPAIR 
    clotrimazole spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55451-010
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE0.06 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    QUATERNIUM-16 (UNII: K4H0FG9I2T)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    DYMANTHINE (UNII: 066975NG22)  
    PROPYLENE GLYCOL, (S)- (UNII: 942194N4TD)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55451-010-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333C01/21/2020
    Labeler - Zhejiang Shiao Technology Co., Ltd. (554518353)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang Shiao Technology Co., Ltd.554518353manufacture(55451-010)
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