Label: ALCOHOL DISINFECTANT- alcohol 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 August 11, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 75%±5% v/v

  • Purpose

    Antimicrobial

  • Use

    Alcohol Disinfectant to help reduce bacteria on skin.

  • Warnings

    • For external use only.
    • Flammable. Keep away from fire or flame.
  • Do not use

    • in children less than 2 years 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

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a Poison Control center immediately.

  • Directions

    For external use on the skin, it can also be sprayed on the surface of objects such as toilets, chairs, handrails, elevators, corridors, etc.

  • Other information

    • Store below 110℉(43℃)
    • May discolor certain fabrics.
  • Inactive ingredients

    DEIONIZED WATER

  • Package Label - Principal Display Panel

    930 mL NDC: 56084-025-01 930mL label

    5000 mL NDC: 56084-025-02 5000mL label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL DISINFECTANT 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:56084-025
    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:56084-025-01930 mL in 1 BOTTLE; Type 0: Not a Combination Product08/11/2020
    2NDC:56084-025-025000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/11/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/11/2020
    Labeler - Zhejiang RIFESHOW Cosmetics Co., Ltd. (560843477)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zhejiang RIFESHOW Cosmetics Co., Ltd.560843477manufacture(56084-025)
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