BAG BALM FIRST AID (PETROLATUM) OINTMENT [DENISON PHARMACEUTICALS, LLC]

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BAG BALM FIRST AID (PETROLATUM) OINTMENT [DENISON PHARMACEUTICALS, LLC]
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NDC 0295-1031-18
Set ID 8165d440-80ee-1faf-e053-2a91aa0a7b2a
Category HUMAN OTC DRUG LABEL
Packager Denison Pharmaceuticals, LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • ACTIVE INGREDIENT

    Active ingredient

    Petrolatum, 84.3%

  • PURPOSE

    Purpose

    Skin Protectant

  • INACTIVE INGREDIENT

    Inactive ingredients

    Benzethonium Chloride, Lanolin, Paraffin Wax, Purified Water

  • QUESTIONS

    Questions or comments?

    1-844-424-2256 • www.bagbalm.com

  • DOSAGE & ADMINISTRATION

    Directions

    Apply as needed

  • 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.

  • WARNINGS

    Warnings

    For external use only

    When using this product do not get into eyes

    Stop use and ask a doctor if

    • condition worsens
    • symptoms last more than 7 days or clear up and occur again within a few days

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns
  • INDICATIONS & USAGE

    Uses

    • temporarily protects minor: cuts scrapes burns
    • temporarily protects and helpsp relieve chapped or cracked skin and lips
    • helps protect from the drying effects of wind and cold weather
  • PRINCIPAL DISPLAY PANEL

    Bag Balm®

    Skin Protectant

    First Aid

    For Minor Cuts, Burns, Scrapes, or Skin Abrasions

    frangrance gfree

    Net Wt. 4.0 oz

    Since 1899, Bag Balm® has been helping to heal compromised skin caused by Vermont's rugged Northeast Kingdom.

    Bag Balm ® First Aid Skin Protectant is uniquely formulated to protect and soothe minor cuts, burns, scrapes or skin abrasions. A medicated ointment to help heal and restore skin.

    Vermont's Original, LLC

    Lyndonville, VT 05851

    label

  • INGREDIENTS AND APPEARANCE
    BAG BALM FIRST AID 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-1031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM84.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    WATER (UNII: 059QF0KO0R)  
    LANOLIN (UNII: 7EV65EAW6H)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-1031-18113 g in 1 CAN; Type 0: Not a Combination Product02/08/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/08/2019
    Labeler - Denison Pharmaceuticals, LLC (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(0295-1031)
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