Label: CARMEX CLASSIC LIP BALM MEDICATED TRIPLE FORCE FORMULA- white petrolatum salve

  • NDC Code(s): 10210-0054-1, 10210-0054-2
  • Packager: Carma Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • Drug Facts

  • Active Ingredients

    White Petrolatum 41.25%

    Purpose

    Lip Protectant

  • Uses

    • helps prevent, protect, and relieve chapped lips
  • Warnings

    For external use only

    When using this product:

    keep out of eyes. Rinse with water to remove.

    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

    • deep puncture wounds
    • serious burns
    • animal bites

    Keep out of reach of children.

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

  • Directions

    • apply as needed
  • Other Information

    • this is a personal care item, and should be used by one individual only
    • protect this product from excessive heat and direct sun
  • Inactive Ingredients

    lanolin, beeswax, cetyl esters, paraffin, theobroma cacao seed butter, camphor, menthol, salicylic acid, phenol, vanillin, flavor

  • Package Labeling:10210-0054-1

    Label08

  • Package Labeling:10210-0054-2

    Label09

  • INGREDIENTS AND APPEARANCE
    CARMEX CLASSIC LIP BALM MEDICATED TRIPLE FORCE FORMULA 
    white petrolatum salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (PETROLATUM - UNII:4T6H12BN9U) WHITE PETROLATUM453 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    MENTHOL (UNII: L7T10EIP3A)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    PHENOL (UNII: 339NCG44TV)  
    VANILLIN (UNII: CHI530446X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0054-11 in 1 BLISTER PACK01/01/2023
    17.5 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:10210-0054-23 in 1 BLISTER PACK01/01/2023
    27.5 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM016B01/01/2023
    Labeler - Carma Laboratories, Inc. (006090153)
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