Label: BIOGERM SANITIZER- benzalkonium chloride spray

  • 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 18, 2021

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  • Active Ingredient(s)

    Benzalkonium Chloride 0.13% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, full body Sanitizer

  • Use

    Full body Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • 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

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.
  • Other information

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

    Propylene glycol, glycerin, aloe vera leaf, water, metylparaben

  • Package Label - Principal Display Panel

    60 g NDC: 77251-005-01

    Biogerm Spray 100 g

    190 g NDC: 77251-005-02

    Biogerm Spray 190 g

    300 g NDC: 77251-005-03

    Bioferm Spray 300 g

    430 g NDC: 77251-005-04

    Biogerm Spray 430 g

  • INGREDIENTS AND APPEARANCE
    BIOGERM SANITIZER 
    benzalkonium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77251-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77251-005-0160 g in 1 BOTTLE; Type 0: Not a Combination Product10/26/2020
    2NDC:77251-005-02190 g in 1 BOTTLE; Type 0: Not a Combination Product10/26/2020
    3NDC:77251-005-03300 g in 1 BOTTLE; Type 0: Not a Combination Product10/26/2020
    4NDC:77251-005-04430 g in 1 BOTTLE; Type 0: Not a Combination Product10/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/26/2020
    Labeler - QUIMICA ROSMAR S.A. DE C.V. (814223475)
    Establishment
    NameAddressID/FEIBusiness Operations
    QUIMICA ROSMAR S.A. DE C.V.814223475manufacture(77251-005) , label(77251-005) , pack(77251-005)
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