BAG BALM SKIN PROTECTANT (PETROLATUM) OINTMENT [VERMONT`S ORIGINAL, LLC]

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BAG BALM SKIN PROTECTANT (PETROLATUM) OINTMENT [VERMONT`S ORIGINAL, LLC]
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NDC 69845-031-02, 69845-031-04
Set ID a823d9cc-6d37-4276-aa50-8c98bdd5c837
Category HUMAN OTC DRUG LABEL
Packager VERMONT`S ORIGINAL, LLC
Generic Name
Product Class
Product Number
Application Number PART347
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  • ACTIVE INGREDIENT

    Active ingredientPurpose
    Petrolatum 84.3%Skin Protectant
  • Uses

    • temporarily protects minor: • cuts • scrapes • burns
    • temporarily protects and helps relieve chapped or cracked skin and lips
    • helps protect from the drying effects of wind and cold weather
  • 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
  • Keep out of reach of children.

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

  • DOSAGE & ADMINISTRATION

    Directions Apply as needed

  • INACTIVE INGREDIENT

    Inactive Ingredients Benzethonium Chloride, Lanolin, Paraffin Wax, Purified Water

  • QUESTIONS

    Questions? 1-844-424-2256 • www.bagbalm.com

  • PACKAGE LABEL

    BAG BALM®
    SKIN PROTECTANT

    FIRST AID
    For Minor Cuts, Burns, Scrapes, or Skin Abrasions

    fragrance free

    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 1

    ● EST 1899 ●

    VERMONT'S ORIGINAL

    BAG BALM®

    Label 2
  • INGREDIENTS AND APPEARANCE
    BAG BALM SKIN PROTECTANT 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69845-031
    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)  
    Lanolin (UNII: 7EV65EAW6H)  
    Paraffin (UNII: I9O0E3H2ZE)  
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69845-031-04113 g in 1 CAN; Type 0: Not a Combination Product03/01/2018
    2NDC:69845-031-0257 g in 1 TUBE; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/01/2018
    Labeler - VERMONT`S ORIGINAL, LLC (079593652)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(69845-031)
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