Label: CUROLOGY BARRIER BALM- skin barrier balm ointment

  • NDC Code(s): 82575-302-01, 82575-302-02, 82575-302-03, 82575-302-04, view more
    82575-302-05, 82575-302-06
  • Packager: Curology
  • Category: HUMAN OTC DRUG LABEL

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 September 6, 2023

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  • ACTIVE INGREDIENT

    Dimethicone 13%

    Petrolatum 41.9%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    • 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
      1. cuts
      2. scrapes
      3. burns

    For External Use Only

    Apply as needed

  • 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, Water, Zinc Oxide, Tocopheryl Acetate, Sodium Hyaluronate, Triethoxycaprylylsilane, BHT.

  • 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

    Directions

    Apply as needed

  • PRINCIPAL DISPLAY PANEL

    15g tube primary container image15g carton artwork with drug facts box28g tube primary artwork image28g carton artwork with drug facts box48g tube primary artwork image48g tube carton artwork with drug facts box

  • INGREDIENTS AND APPEARANCE
    CUROLOGY BARRIER BALM 
    skin barrier balm ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82575-302
    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
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    WATER (UNII: 059QF0KO0R)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    Product Characteristics
    Colorwhite (Paste) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82575-302-021 in 1 CARTON10/02/2023
    1NDC:82575-302-0115 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:82575-302-041 in 1 CARTON10/02/2023
    2NDC:82575-302-0328 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:82575-302-061 in 1 CARTON10/02/2023
    3NDC:82575-302-0548 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01610/02/2023
    Labeler - Curology (104103284)
    Establishment
    NameAddressID/FEIBusiness Operations
    Autumn Harp, Inc.064187883manufacture(82575-302)
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