Label: 75% ALCOHOL DISINFECTANT 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 May 24, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient


    Ethyl Alcohol 75%

  • Purpose


    Antiseptic

  • Uses


    For hand sanitizing to reduce bacteria on the skin.

  • Warnings


    For extermal use only-hands. Flamable. Keep aways from heat and flame.

  • Do not use


    in children less than 2 months of ageon open skin wounds

  • When using this product


    Keep out of eyes,ears,and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Do not inhale or ingest. Stop use and ask a doctor if skinimitation develops.These may be signs of a serious conditionNot suitable for people who are allergic to alcohol. Keep out of reach of children. If swallowed, get medical help or contact
    a Poison Control Center right away.

  • STOP USE

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry.
    Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

  • Inactive ingredients


    Water,Glycerol,Fragrance

  • Package Label - Principal Display Panel

    100 ml label 480 ml label 3785 ml label

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL DISINFECTANT 
    75% alcohol disinfectant spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75129-013
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75129-013-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product04/18/2020
    2NDC:75129-013-02480 mL in 1 BOTTLE; Type 0: Not a Combination Product04/18/2020
    3NDC:75129-013-033785 mL in 1 BOTTLE; Type 0: Not a Combination Product04/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/18/2020
    Labeler - Shanghai Rayshine ENVI-TECH Developing CO., Ltd. (420836386)
    Registrant - Shanghai Rayshine ENVI-TECH Developing CO., Ltd. (420836386)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Rayshine ENVI-TECH Developing CO., Ltd.420836386manufacture(75129-013)