Label: GERMISEPT BRAN ANTIBACTERIAL MOIST- benzalkonium chloride swab

  • 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 January 3, 2023

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  • Drug Fact

  • Active ingredient

    Benzalkonium Chloride 0.115%

    Purpose

    Antibacterial

  • Uses:

    Decrease bacteria on the skin.

  • Warnings

    • For external use only.

    When using this product

    • avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Do not use

    • if irritation and redness develop.

    Stop use and ask a doctor

    • if condition persists for more than 72 hours.

    Keep out of reach of children/

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

    • Open resealable label, remove one wipe to use.
    • Wipe hands thoroughly with product and allow to dry without wiping.
    • Close resealable label after use to retain moisture.
  • Other information

    • Store below 95° F (35° C) to prevent from drying out.
    • Dispose of wipe in the proper container.
    • Do not flush down the toilet.
  • Inactive ingredients

    2-Bromo-2-Nitropropane-1,3-Diol, Aloe Barbadensis Leaf Extract, Chamomilla Recutita Flower Extract, Citric Acid, Iodopropynyl Butylcarbamate, Lauryl Glucoside, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Sodium Citrate, Tetrasodium EDTA, Water.

  • Package Labeling:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    GERMISEPT BRAN ANTIBACTERIAL MOIST 
    benzalkonium chloride swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70335-310
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.15 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BRONOPOL (UNII: 6PU1E16C9W)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70335-310-301 in 1 CARTON01/10/201911/30/2025
    130 in 1 PACKAGE
    12.98 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/10/201911/30/2025
    Labeler - Innovent Inc. (079973489)
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