Label: SANITIZER- alcohol, citric acid liquid

  • NDC Code(s): 77578-003-01, 77578-003-02
  • Packager: Nutraze, S.C de R.L. de C.V.
  • 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 January 17, 2022

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  • Active ingredient

    Alcohol 80% Purpose: Antiseptic

  • Inactive ingredients

    Glycerin, hydrogen peroxide, purifed water.

  • Use(s)

    Hand Sanitizer Antiseptic solution to help reduce bateria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    Flammable. Keep away from heat or flame.

  • DO NOT USE

    - In children less than 2 months of age

    - In open skin wounds

  • WHEN USING

    Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

  • PURPOSE

    Antiseptic

  • STOP USE

    If irritation or rash occurs. These may be signs of a serious condition.

  • ASK 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.

  • Other information

    - Store between 15-30°C (59-86°F)

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

  • DOSAGE & ADMINISTRATION

    Topical

  • Principal Display Panel

    500 mL NDC:77578-003-01

    Sanybeda

  • Package Label- Principal Display Panel

    1000 L NDC: 77578-003-02

    Sanybeda

  • INGREDIENTS AND APPEARANCE
    SANITIZER 
    alcohol, citric acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77578-003
    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
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 mL  in 100 mL
    WATER (UNII: 059QF0KO0R) 18.425 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77578-003-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product01/17/2022
    2NDC:77578-003-021000000 mL in 1 CONTAINER; Type 0: Not a Combination Product01/17/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/17/2022
    Labeler - Nutraze, S.C de R.L. de C.V. (951577481)
    Registrant - Nutraze, S.C de R.L. de C.V. (951577481)
    Establishment
    NameAddressID/FEIBusiness Operations
    Nutraze, S.C de R.L. de C.V.951577481manufacture(77578-003)
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