Label: MAXIMUM STRENGTH BETADINE CLEAR- benzalkonium cl and pramoxine hcl spray

  • NDC Code(s): 67618-183-06
  • Packager: Atlantis Consumer Healthcare, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 10, 2024

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  • Drug Facts

    Active ingredients

    Benzalkonium Cl 0.13%

    Pramoxine HCl 1.0%

  • Purpose

    First aid Antiseptic

    Topical analgesic

  • Uses

    First aid to help prevent infection and relieve 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 a doctor before use if you have

    •
    deep or puncture wounds
    •
    serious burns
    •
    animal bites
  • Stop use and ask a doctor if

    •
    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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.

  • 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 sterile bandage
    •
    if bandaged, let dry first
    •
    children under 2 years of age:
    •
    consult a doctor
  • Other information

    •
    protect from freezing
  • Inactive ingredients

    citric acid anhydrous, disodium edetate, flavor, propylene glycol, purified water, sodium citrate dihydrate.

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel


    MAXIMUM STRENGTH

    BETADINE® CLEAR

    FIRST AID SPRAY

    Pain Relieving

    Antiseptic

    Cleansing spray

    ✓
    Ideal for Minor Cuts, wounds, scrapes & Burns
    ✓
    Kills 99.9% of Germs* To prevent Infection
    ✓
    Maximum Strength Pain Relief
    ✓
    No Stinging or Burning

    6 FL OZ (177 mL)

    Dist. by: Atlantis Consumer Healthcare Inc.

    Bridgewater, NJ 08807 USA

    www.betadine.com

    ©2023 Atlantis Consumer Healthcare Inc.

    *commonly associated with skin infections.

    Tamper-Evident: Do not use if imprinted shrink band is broken or missing.

    Betadine is a registered trademark of Atlantis Consumer Healthcare Inc.

    MAXIMUM STRENGTH BETADINE® CLEAR SPRAY 6 OZ 177 ML
  • INGREDIENTS AND APPEARANCE
    MAXIMUM STRENGTH BETADINE CLEAR 
    benzalkonium cl and pramoxine hcl spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67618-183
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 1 mL
    PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67618-183-06177 mL in 1 BOTTLE; Type 0: Not a Combination Product12/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00312/22/2023
    Labeler - Atlantis Consumer Healthcare, Inc. (118983925)
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