Label: BAND AID ANTISEPTIC CLEANSING- benzalkonium chloride, pramoxine hcl spray

  • NDC Code(s): 69968-0729-8
  • Packager: Johnson & Johnson Consumer Inc.
  • 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 9, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Benzalkonium Cl (0.13%)

    Pramoxine HCl (1%)

  • Purposes

    First aid antiseptic

    Topical analgesic

  • Use

    first aid to help prevent infection and temporarily relieve pain or discomfort in minor: · cuts · scrapes · burns

  • Warnings

    • For external use only.

    Do not use · in the eyes · over large area of the body

    • Ask a doctor before use if you have · deep or puncture wounds · animal bites · serious burns

    • condition or symptoms get worse or last more than 1 week
    • symptoms clear up and occur again within a few days

    Keep out of reach of children.

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

  • Directions

    adults and children 2 years of age and older:

    clean the affected area
    spray a small amount of this product on the area 1 to 3 times daily
    may be covered with a sterile bandage
    if bandaged, let dry first

    children under 2 years of age: consult a doctor

  • Other information

    protect from freezing

  • Inactive ingredients

    Water, Propylene Glycol, Disodium EDTA

  • Questions?

    call 800-526-3967 or 215-273-8755 (collect).

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    JOHNSON & JOHNSON CONSUMER INC.
    Skillman, NJ 08558

  • PRINCIPAL DISPLAY PANEL - 237 mL Bottle

    BAND-AID®

    BRAND OF FIRST AID PRODUCTS

    Johnson & Johnson

    ANTISEPTIC

    CLEANSING

    SPRAY

    FIRST AID ANTIBIOTIC

    PAIN RELEIVING SPRAY

    MAX PAIN RELIEF

    Kills 99.99% of germs*

    to prevent infection

    No sting

    For minor cuts, scrapes & burns

    8 FL OZ (237mL)

    Band-Aid-001

  • INGREDIENTS AND APPEARANCE
    BAND AID ANTISEPTIC CLEANSING 
    benzalkonium chloride, pramoxine hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69968-0729
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69968-0729-8237 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/30/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/30/2022
    Labeler - Johnson & Johnson Consumer Inc. (118772437)
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