Label: GERMS BE GONE ANTIBACTERIAL SCENTED- antiseptic hand cream cream

  • NDC Code(s): 50157-524-50
  • 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

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

  • Active Ingredient(s)

    Benzalkonium chloride 0.05 %.

  • Purpose

    Antiseptic skin cleanser

  • Use

    To help reduce bacteria on hands.

  • Warnings

    For external use only.

  • 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

    • Rub thoroughly on hands for at least 30 seconds and allow to dry
    • Supervise children when using this product to avoid swallowing.
    • Adults and children over 2 years
    • For occasional and domestic use
  • Other information

    • Store between 15-30C (59-86F)
    • May discolor certain fabrics or surfaces
  • Inactive ingredients

    Aqua (Water), Propylene Glycol, Isopropyl Myristate, Isopropyl Palmitate, Stearyl Alcohol, Ceteareth-20, Glycerin, Glyceryl Stearate,
    Caprylic/Capric Triglyceride, Stearic Acid, Glycol Stearate, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera Oil (Coconut),
    Petroleum Jelly, Vitamin E (Tocopherol), DMDM Hydantoin, Allantoin, Aloe Barbadensis Leaf Extract, Perfume

  • Package Label - Principal Display Panel

    4

  • INGREDIENTS AND APPEARANCE
    GERMS BE GONE ANTIBACTERIAL  SCENTED
    antiseptic hand cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-524
    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
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    TRICAPRYLIN (UNII: 6P92858988)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-524-5050 mL in 1 BOTTLE; 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    BRANDS INTERNATIONAL CORPORATION243748238manufacture(50157-524)