Label: HAND SANITIZER gel

  • 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 9, 2020

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  • Active Ingredient(s)

    Isopropyl Alcohol 75%v/v

  • Purpose

    Antiseptic

  • Use

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
    For external use only. Flammable. Keep away from heat or flame

  • Warnings

    /

  • Do not use

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

  • WHEN USING

    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

  • 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

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

  • Other information

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

  • Inactive ingredients

    Deionized Water, Aloe Barbadensis Extract, Carbomer, Arginine, Silver Ions

  • Package Label - Principal Display Panel

    70ML 90067-001-01

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:90067-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ARGININE (UNII: 94ZLA3W45F)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    SILVER CATION (UNII: 57N7B0K90A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:90067-001-0170 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Guangzhou Mebamy Cosmetics Co., Ltd. (403327528)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guangzhou Mebamy Cosmetics Co., Ltd.403327528manufacture(90067-001)
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