Label: 75% ALCOHOL spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 25, 2020

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  • DOSAGE & ADMINISTRATION

    Flammable, Keep away from fire or flame.

  • INACTIVE INGREDIENT

    Water

    Methylisothiazolinone

  • INDICATIONS & USAGE

    1. Complete skin disinfection: apply the original solution to the skin for 1 minute;
    2. Object surface disinfection: wipe the object surface with the original solution for 3 minutes.

  • ACTIVE INGREDIENT

    Alcohol

  • KEEP OUT OF REACH OF CHILDREN

    keep out of children

  • PURPOSE

    Disinfection
    Sterilization

  • WARNINGS

    1. Flammable, Keep away from fire or flame;
    2. For external use only;
    3. When using this product, do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water;
    4. Stop use and ask a doctor if irritation or rash appears and lasts;
    5. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL 
    75% alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52897-001
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize125mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52897-001-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/25/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/25/2020
    Labeler - Xiamen Haida Co., Ltd (528972789)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Haida Co., Ltd528972789manufacture(52897-001)
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