Label: ONKO HEALTH- alcohol liquid

  • Category: HUMAN OTC DRUG LABEL

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 January 19, 2021

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  • Active Ingredients

    Alcohol 80%

  • Purposes

    Antiseptic.

  • Uses

    · Helps reduce bacteria that potentially can cause disease.

    · For use when soap and water are not available.

  • Warnings

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

    • In children less than 2 months of age
    • On 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.
    • Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
  • 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
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Other Information

    • Store between 15-30C (59-86F)

    ● Avoid freezing and excessive heat above 40C (104F)

  • Inactive Ingredients

    Glycerin, hydrogen peroxide, purified water USP

  • Product Image

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  • Product Image 236mL

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  • Product Image 473mL

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  • Package Label

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  • Product Image 1000mL

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  • INGREDIENTS AND APPEARANCE
    ONKO HEALTH 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77283-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77283-003-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/12/2021
    2NDC:77283-003-02236 mL in 1 BOTTLE; Type 0: Not a Combination Product01/12/2021
    3NDC:77283-003-03473 mL in 1 BOTTLE; Type 0: Not a Combination Product01/12/2021
    4NDC:77283-003-04561 mL in 1 BOTTLE; Type 0: Not a Combination Product01/12/2021
    5NDC:77283-003-051000 mL in 1 BOTTLE; Type 0: Not a Combination Product01/12/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/12/2021
    Labeler - ONKO PHARMACEUTICALS USA INC (114603246)
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