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 April 2, 2022

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  • Active Ingredient(s)

    Ethyl Alcohol 75% v/v

  • Purpose

    Antimicrobial

  • Warnings

  • 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

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

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

  • Other information

    Store below 110°F(43°C)

  • Inactive ingredients

    Water, Glycerin, Carbomer, Aloe Vera, Trithanolamine, Vitamine E

  • INDICATIONS & USAGE

    Hand sanitizer to help reduce bacteria on skin.

  • Package Label - Principal Display Panel

    78565-003-08 30 ml78565-003-08 30ml78565-003-09 59 ml78565-003-09 59ml30730930530630823659 122730 1302592100ML59100

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78565-003
    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
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL SUCCINATE, D- (UNII: LU4B53JYVE)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78565-003-0230 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:78565-003-0330 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:78565-003-0430 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:78565-003-0559 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    5NDC:78565-003-06227 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    6NDC:78565-003-07236 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    7NDC:78565-003-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    8NDC:78565-003-0830 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    9NDC:78565-003-0959 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 - Meixin Beauty & Health Care Products Co., Ltd. (421458605)
    Establishment
    NameAddressID/FEIBusiness Operations
    Meixin Beauty & Health Care Products Co., Ltd.421458605manufacture(78565-003)
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