Label: CHAPICE MEDICATED BALM- camphor, menthol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 1, 2013

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

View All Sections
  • Active ingredient

    Camphor (1.7%), Menthol (0.7%)

  • Purpose

    External Analgesic, External Analgesic

  • Keep Out of Reach of Children

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

  • Uses

    Helps to provide relief of the symptoms of cold sores and dry chapped lips.

  • Warnings

    For external use only. When using this product: avoid contact with eyes. Stop use and ask a doctor if irritation and rash occur.

  • Directions

    Apply freely to affected area. Consult a physician for use on children under 2 years of age.

  • Inactive Ingredients

    Copernicia Cerifera (Carnauba) Wax, Flavor, Lanolin, Microcrystalline Wax, Mineral Oil, Ozokerite, Petrolatum, Phenol, Salicylic Acid, Theobroma Cacao (Cocoa) Seed Butter.

  • Package/Label Principal Display Panel

    Front and Back of ChapIce Medicated Balm
  • INGREDIENTS AND APPEARANCE
    CHAPICE MEDICATED BALM 
    camphor, menthol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63645-161
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)1.700 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.700 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP) 1.053 mg  in 1 g
    PHENOL (UNII: 339NCG44TV) 0.400 mg  in 1 g
    EUCALYPTUS OIL (UNII: 2R04ONI662) 0.500 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) 83.947 mg  in 1 g
    CERESIN (UNII: Q1LS2UJO3A) 1.000 mg  in 1 g
    LANOLIN (UNII: 7EV65EAW6H) 8.000 mg  in 1 g
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63645-161-041 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34603/15/2013
    Labeler - OraLabs (801824756)
    Registrant - OraLabs (801824756)
    Establishment
    NameAddressID/FEIBusiness Operations
    OraLabs801824756MANUFACTURE(63645-161) , LABEL(63645-161)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!