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 May 20, 2020

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  • Active Ingredient(s)

    Ethyl Alcohol 75% v/v. Purpose: Antimicrobial

  • Purpose

    Antimicrobial.

  • Use

    Recommended uses:

    External use to help reduce bacteria on the skin.

  • Warnings

    Cautions and Warning:

    DANGER! Flammable warning. Keep away from open flame and sources of heat.
    For external use only.

  • Do not use

    Contraindications:

    Do not use on children/infants less than 2 years of age (unless directed by a doctor/physician/health care practitioner/health care provider/health care profession).

  • WHEN USING

    When using this product avoid contact with eyes.

  • STOP USE

    Stop use and ask/consult a doctor/physician/health care practitioner/health care provider/health care profession if irritation develops and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.

  • Directions

    Superise children when they use this product. For occasional and personal dosmetic use. Rub thoroughly into hands for at least 30 seconds. Allow to dry.

  • Other information

    Security Package: Security feature is self-evident.

    Waste disposal: The disposal of this product and container shall be in accordance with local/national regulations.

  • Inactive ingredients

    Aqua, Glycerin, Carbomer, Parfum, Triethanolamine.

  • Package Label - Principal Display Panel

    Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77607-100
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    WATER (UNII: 059QF0KO0R)  
    DICHROSTACHYS CINEREA WHOLE (UNII: N27D64ME6P)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77607-100-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
    2NDC:77607-100-0360 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
    3NDC:77607-100-05100 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
    4NDC:77607-100-08200 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
    5NDC:77607-100-09236 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
    6NDC:77607-100-12300 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
    7NDC:77607-100-15500 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
    8NDC:77607-100-19946 mL in 1 BOTTLE; Type 0: Not a Combination Product05/19/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/19/2020
    Labeler - Xiamen Afgamarine Biotechnology Co., Ltd. (420485152)
    Registrant - A03 Lab of BTS (548009541)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Afgamarine Biotechnology Co., Ltd.420485152manufacture(77607-100) , label(77607-100)
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