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
  • Packager: Carma Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 21, 2021

If you are a consumer or patient please visit this version.

  • 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

  • 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
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) 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
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/26/2016
    Labeler - Carma Laboratories, Inc. (006090153)