Label: FIRST AID ANTISEPTIC PAIN RELIEVING- benzalkonium chloride,pramoxine hydrochloride spray

  • Category: HUMAN OTC DRUG LABEL

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 November 19, 2021

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  • ACTIVE INGREDIENT

    BENZALKONIUM CHLORIDE;
    PRAMOXINE HYDROCHLORIDE;

  • PURPOSE

    First aid antibiotic
    Topical analgesic

  • INDICATIONS & USAGE

    first aid to help prevent infection and for the temporary relief of pain or discomfort in minor:
    • cuts
    • scrapes
    • burns

  • WARNINGS

    For external use only

  • DO NOT USE

    • in the eyes
    • over large areas of the body

  • ASK DOCTOR

    • deep or puncture wounds
    • animal bites
    • serious burns

  • STOP USE

    • condition or symptoms get worse or last more than one 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 Centre right away.

  • DOSAGE & ADMINISTRATION

    • 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 SAFETY INFORMATION

    Store at Room Temperature

  • INACTIVE INGREDIENT

    Water, Propylene Glycol, Edetate Disodium

  • KEEP OUT OF REACH OF CHILDREN

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

  • PRINCIPAL DISPLAY PANEL

    NDC: 82199-610-26 7.7ml in 1 Vial

    7.7ml label

  • INGREDIENTS AND APPEARANCE
    FIRST AID ANTISEPTIC PAIN RELIEVING 
    benzalkonium chloride,pramoxine hydrochloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82199-610
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 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:82199-610-267.7 mL in 1 VIAL; Type 0: Not a Combination Product11/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34811/19/2021
    Labeler - Shandong Ruian Pharmaceutical Co.,Ltd. (723845363)
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