Label: BAG BALM SKIN PROTECTANT- petrolatum ointment

  • NDC Code(s): 69845-031-02, 69845-031-04
  • Packager: VERMONT`S ORIGINAL, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 14, 2017

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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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