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 September 18, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol75%

  • Purpose

    Antiseptic

  • Use

    Sanitizing spray to help reduce bacteria, viruses and other microbes on the skin.

  • Warnings

    Flammable—keep away from fire
    For external use only

    Keep out of reach of children

    Do not use in or near the eyes.
    In case of contact, rinse eyes thoroughly with water
    If product is swallowed, get medical help or contact a poison control center immediately

    May discolor certain fabrics or surfaces
    In case of rash, stop use immediately.

  • Do not use

    Do not use in or near the eyes.
    In case of contact, rinse eyes thoroughly with water
    If product is swallowed, get medical help or contact a poison control center immediately

  • WHEN USING SECTION

    Keep out of reach of children

    Do not use in or near the eyes.
    In case of contact, rinse eyes thoroughly with water
    If product is swallowed, get medical help or contact a poison control center immediately

    May discolor certain fabrics or surfaces
    In case of rash, stop use immediately.

  • STOP USE

    May discolor certain fabrics or surfaces
    In case of rash, stop use immediately.

  • Keep out of reach of children

    Keep out of reach of children

  • Directions

    Spray product on hands. Rub hands together briskly until dry. Children under six years of age should be supervised. Store below 110°F (43°C).

  • Other information

    /

  • Inactive ingredients

    Water

  • Package Label - Principal Display Panel

    78414-005-01 118ML

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL 
    75% alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78414-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78414-005-01118 mL in 1 BOTTLE; Type 0: Not a Combination Product09/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/18/2020
    Labeler - Guangzhou caolvxiang Biotechnology Co.,Ltd (547949400)
    Registrant - Guangzhou caolvxiang Biotechnology Co.,Ltd (547949400)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou caolvxiang Biotechnology Co.,Ltd547949400manufacture(78414-005)