Label: 75% ALCOHOL DISINFECTANT liquid

  • 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 December 27, 2020

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

  • Active Ingredient(s)

    ALCOHOL DENAT. 75%

  • Purpose

    efficient to kill staphylococcus aureus,e. coil, pseudo-monas aeruginosa and candida albicans etc

  • Use

    1.Hand disinfection:follow the standard method to use soap to wash hands,rinse with running water,dry with sterile towels,then direct spray this product on hands and forearms until moist,wait for 3 minutes, rub hands until dry.
    2.General object surface disinfection:directly spray on the object surface for until moist,wait for 3-5 minutes.

  • Warnings

    1.EXTREMELY FLAMMABLE.

    pressurized container; protect from sunlight and don't expose to temperatures exceeding 50℃ . Don't pierce or burn, even after use. Don't spray on a naked flame or any incandescent material. Keep it away from the reach of children . Don't spray towards eyes.

    2.External disinfectant should not be taken orally and kept out of reach of children.

    3.Use with caution if allergic to alcohol.

    4.It should not be used to disinfect fat-soluble surface.

    5.This product is irritating to wounds and mucous membranes.

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Directions

    • 1.Hand disinfection:follow the standard method to use soap to wash hands,rinse with running water,dry with sterile towels,then direct spray this product on hands and forearms until moist,wait for 3 minutes, rub hands until dry.
    • 2.General object surface disinfection:directly spray on the object surface for until moist,wait for 3-5 minutes.
  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients

    Water

  • Package Label - Principal Display Panel

    500 ml in 1 bottle NDC:81276-015-01

    LABEL

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL DISINFECTANT 
    75% alcohol disinfectant liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81276-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL375 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code SHUANGNIAO
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81276-015-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Dongyang Medical & Hygienic Articles Co., Ltd. (530310429)
    Registrant - Dongyang Medical & Hygienic Articles Co., Ltd. (530310429)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dongyang Medical & Hygienic Articles Co., Ltd.530310429manufacture(81276-015) , label(81276-015)