Label: CARMEX CLASSIC LIP BALM MEDICATED (camphor- synthetic, petrolatum salve

  • NDC Code(s): 10210-0022-1, 10210-0022-2, 10210-0022-3, 10210-0022-4, view more
    10210-0022-5, 10210-0022-6, 10210-0022-7
  • Packager: Carma Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 21, 2023

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  • Drug Facts

  • Active Ingredients

    Camphor 1.70%

    White Petrolatum 45.30%

    Purpose

    External Analgesic

    Lip Protectant

  • Uses

    • helps provide relief of symptoms of cold sores and dry 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 on:

    • 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 to lips not more than 3 to 4 times daily
    • children under 2 years of age: ask a doctor
  • 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, cetyl esters, theobroma cacao seed butter, paraffin, beeswax, menthol, salicylic acid, phenol, vanillin, flavor

  • Package Labeling:

    Medicated

    2

  • Package Labeling:10210-0022-7

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    CARMEX CLASSIC LIP BALM MEDICATED 
    camphor (synthetic), petrolatum salve
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10210-0022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.7 g  in 100 g
    WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4) WHITE PETROLATUM45.3 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    MENTHOL (UNII: L7T10EIP3A)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    PHENOL (UNII: 339NCG44TV)  
    VANILLA (UNII: Q74T35078H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10210-0022-11 in 1 BLISTER PACK09/26/2016
    17.5 g in 1 JAR; Type 0: Not a Combination Product
    2NDC:10210-0022-23 in 1 PACKAGE09/26/2016
    27.5 g in 1 JAR; Type 0: Not a Combination Product
    3NDC:10210-0022-37.5 g in 1 JAR; Type 0: Not a Combination Product09/26/2016
    4NDC:10210-0022-41 in 1 BLISTER PACK09/26/2016
    410 g in 1 TUBE; Type 0: Not a Combination Product
    5NDC:10210-0022-53 in 1 PACKAGE09/26/2016
    510 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:10210-0022-610 g in 1 TUBE; Type 0: Not a Combination Product09/26/2016
    7NDC:10210-0022-712 in 1 BOX01/01/2023
    710 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01709/26/2016
    Labeler - Carma Laboratories, Inc. (006090153)
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