Label: HAND SANITIZER spray

  • 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 July 2, 2020

If you are a consumer or patient please visit this version.

  • Active Ingredient(s)

    Ethyl Alcohol 75% v/v

  • Purpose

    Antimicrobial

  • Warnings

    For external use only. Only on hands
    Flammable, keep away from fire or flam

  • Do not use

    Do not use in or near eyes In case of contact
    rinse thoroughly with water

  • WHEN USING

    /

  • STOP USE

    Stop use and ask a doctor if irritation and redness
    develop and persists for more than 72 hours

  • 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

    Put enough product on palm and rub hands until drya
    Children under 6 years of age should be supervised while using this

    product

  • Other information

    /

  • Inactive ingredients

    Auqa(water), glycerin, parfum

  • INDICATIONS & USAGE

    To decrease bacteria on skin without soap or water
    Recommended for repeated use

  • Package Label - Principal Display Panel

    5915936059592

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78565-002
    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
    METHYL BENZOATE (UNII: 6618K1VJ9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78565-002-0259 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    2NDC:78565-002-0159 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    3NDC:78565-002-0359 mL in 1 BOTTLE; Type 0: Not a Combination Product03/30/2020
    4NDC:78565-002-0460 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(78565-002)