Label: 70% ALCOHOL HAND SANITIZER GEL- 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 May 6, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 70%±5 v/v. Purpose: Antimicrobial

  • Purpose

    purpose:Antimicrobial

  • Use

    Hand Sanitizer to help reduce bacteria on the skin that may cause disease.

  • Warnings

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

  • WHEN USING

    When using this product avoid contact with face, eyes, and broken skin . In case of eye contact , flush with plenty of water and seek medical advice.

  • STOP USE

    Stop use and ask a doctor if imiation or redness develops.

  • 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

    wet hands thoroughly with product and rub into skin until dry. children under 6years of age should be supervised by an adult when using.

  • Other information

    Store at room temperature,may discolor certain fabrics

  • Inactive ingredients

  • Package Label - Principal Display Panel

    package

    60ml NDC:77372-001-01

  • INGREDIENTS AND APPEARANCE
    70% ALCOHOL HAND SANITIZER GEL 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77372-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 940 (UNII: 4Q93RCW27E) 0.4 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.4 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77372-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/06/2020
    Labeler - CJ Global Inc (618947332)
    Establishment
    NameAddressID/FEIBusiness Operations
    ZHEJIANG RIFESHOW COSMETICS CO.,LTD560843477manufacture(77372-001)
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