Label: GERMS BE GONE SANITIZER SCENTED- hand sanitizer solution

  • NDC Code(s): 50157-526-23
  • Packager: Brands International Corporation
  • 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 August 14, 2021

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.13% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic skin cleanser

  • Use

    Effective in destroying harmful bacteria to provide antiseptic cleaning

  • Warnings

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

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • STOP USE

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • 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

    Adults and children over 2 years: For occasional and personal domestic use Supervise children when they use this product rub
    thoroughly into hands for at least 30 seconds. Allow to dry.

  • Other information

    Store between 15-30C (59-86F). Avoid freezing and excessive heat above 40C (104F)

    may discolor certain fabrics or surfaces.

  • Inactive ingredients

    Aqua (Water), Lauramine oxide, Glycerin, Cetrimonium Chloride, Vitamin E (Tocopherol), Aloe Barbadensis Leaf Extract, DMDM Hydantoin

  • Package Label - Principal Display Panel

    6

  • INGREDIENTS AND APPEARANCE
    GERMS BE GONE SANITIZER  SCENTED
    hand sanitizer solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-526
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    ALOE (UNII: V5VD430YW9)  
    CETRIMONIUM CHLORIDE (UNII: UC9PE95IBP)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-526-23236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product08/14/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A08/14/2021
    Labeler - Brands International Corporation (243748238)
    Registrant - Brands International Corporation (243748238)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International Corporation243748238manufacture(50157-526)
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