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 September 7, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 75% v/v

  • Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Hand sanitizer to help reduce bacteria on skin.

  • Warnings

    Flammable. Keep away from fire or flame.
    For external use only.

    When using this product do not use in or near the eyes.
    In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor in case of rash or irritation stop using and ask a doctor.

    Keep out of reach of chlldren.if ingested call your doctor or go to the emergency services.

  • Do not use

    do not use in or near the eyes.

  • WHEN USING

    When using this product do not use in or near the eyes.
    In case of contact, rinse eyes thoroughly with water.

    Stop use and ask a doctor in case of rash or irritation stop using and ask a doctor.

    Keep out of reach of chlldren.if ingested call your doctor or go to the emergency services.

  • STOP USE

    Stop use and ask a doctor in case of rash or irritation stop using and ask a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of chlldren.if ingested call your doctor or go to the emergency services.

  • Directions

    Put enough product in your palm to cover hands and rubands together brisky until dry.
    Children under 6 years of age should be supervised when using.

  • Other information

    Store below(43°C)

  • Inactive ingredients

    Acry-lates/c10-30 Alkyl Acrylate crosspolymer, Triethanolamine,Sargassum Fusiforme Extract,Poterium Sanguisorba Root Extract,Parfum.

  • Package Label - Principal Display Panel

    78565-016-01 500ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78565-016
    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
    FRAGRANCE CLEAN ORC0600327 (UNII: 329LCV5BTF)  
    SARGASSUM FUSIFORME (UNII: X436TJ4A11)  
    SANGUISORBA MINOR ROOT (UNII: 11YGU8I0TT)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78565-016-01500 mL in 1 BOTTLE; Type 0: Not a Combination Product09/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/07/2020
    Labeler - Meixin Beauty & Health Care Products Co., Ltd. (421458605)
    Establishment
    NameAddressID/FEIBusiness Operations
    Meixin Beauty & Health Care Products Co., Ltd.421458605manufacture(78565-016)
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