Label: BROMPTON AND LANGLEY HAND SANITIZER- alcohol 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 October 8, 2021

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  • Active ingredient

    Alcohol 70% w/w

    Purpose

    Antiseptic

  • Use

    Antiseptic Cleanser, helps decrease bacteria on skin.

  • Warnings

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

    When using this product

    Avoid contact with the eyes; in case of contct, flush eyes with water.

    Stop use and ask a doctor if

    Irritation or redness develops and persists.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Place enough product on your palm to thoroughly cover your hands.
    • Rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Store below 110°F (43°C). May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Aqua/Water/Eau, Glycerin, Carbomer, Triethanolamine, Fragrance (Parfum).

  • Questions?

    1-800-548-4097

  • Label copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    BROMPTON AND LANGLEY HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77607-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 934 (UNII: Z135WT9208)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77607-005-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/06/2021
    2NDC:77607-005-0230 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/06/2021
    3NDC:77607-005-0330 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/06/2021
    4NDC:77607-005-0430 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/06/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/06/2021
    Labeler - Xiamen Afgamarine Biotechnology Co., Ltd. (420485152)
    Registrant - Xiamen Afgamarine Biotechnology Co., Ltd. (420485152)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Afgamarine Biotechnology Co., Ltd.420485152manufacture(77607-005)
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