Label: BARRIER BALM ointment

  • NDC Code(s): 51514-0363-1, 51514-0363-2, 51514-0363-3, 51514-0363-4, view more
    51514-0363-5, 51514-0363-6
  • Packager: Autumn Harp, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 1, 2023

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  • ACTIVE INGREDIENT

    Active Ingredient

    Petrolatum 41.9%

    Dimethicone 13.0%

  • PURPOSE

    Helps prevent, temporarily protects and helps relieve chafed, chapped or cracked skin

    Helps prevent and protect from the drying effects of wind and cold weather

    Temporarily protects minor cuts, scrapes, burns

  • INDICATIONS & USAGE

    Directions

    Apply as needed

  • WARNINGS

    Warnings

    For external use only

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

    Do not use on deep or puncture wounds, animal bites, serious burns

    When using this product do not get into eyes

    Stop use and ask doctor if condition worsens, symptoms last more than 7 days or clear up and occur again within a few days

  • INACTIVE INGREDIENT

    Caprylic/Capric triglyceride, Butyrospermum Parkii (Shea Butter), Aluminum Starch Octenylsuccinate, Synthetic Wax, Polyhydroxystearic Acid, Sodium Hyaluronate, Water, Zinc Oxide, Tocopheryl Acetate, Triethoxycaprylylsilane

  • QUESTIONS

    Questions?

    858-859-1188

  • 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

  • DOSAGE & ADMINISTRATION

    Apply as needed

  • PRINCIPAL DISPLAY PANEL

    48g tube carton artwork15g carton artwork with drug facts box28g carton artwork with drug facts box15g tube primary container image28g tube primary artwork image48g tube primary artwork image

  • INGREDIENTS AND APPEARANCE
    BARRIER BALM 
    barrier balm ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51514-0363
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE 20 (UNII: H8YMB5QY0D) (DIMETHICONE 20 - UNII:H8YMB5QY0D) DIMETHICONE 2013 g  in 100 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM41.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51514-0363-21 in 1 CARTON10/02/2023
    1NDC:51514-0363-115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:51514-0363-41 in 1 CARTON10/02/2023
    2NDC:51514-0363-328 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:51514-0363-61 in 1 CARTON10/02/2023
    3NDC:51514-0363-548 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01610/02/2023
    Labeler - Autumn Harp, Inc. (064187883)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp064187883manufacture(51514-0363)
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