Label: CHAPSTICK MEDICATED- camphor, menthol, petrolatum, phenol stick

  • NDC Code(s): 0573-0720-12, 0573-0720-51, 0573-0720-70
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • 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 November 9, 2020

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  • Active Ingredient

    Camphor 1%

    Menthol 0.6%

    Petrolatum 41%

    Phenol 0.5%

  • Purposes

    External analgesic

    External analgesic

    Skin protectant

    External analgesic

  • Uses

    •
    helps prevent and temporarily protects chafed, chapped or cracked lips
    •
    temporary relief of pain associated with fever blisters and cold sores
    •
    helps prevent and protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

    When using this product avoid contact with the eyes.

    Stop use and ask a doctor if

    •
    condition worsens
    •
    symptoms persist for more than 7 days or clear up and occur again within a few days

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    •
    adults and children 2 years of age and older: apply to lips not more than 3 to 4 times daily
    •
    children under 2 years of age: ask a doctor
  • Other information

    •
    store at 20-25°C (68-77°F)
  • Inactive ingredients

    arachidyl propionate, carnauba wax, cetyl alcohol, cocoa butter, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, white wax

  • Questions or comments?

    call weekdays from 9 AM to 5 PM at 1-877-227-3421

    Additional information

    Marketed by: Pfizer

    Madison, NJ 07940 USA

    © 2017 Pfizer Inc.

    For most recent product information, visit www.chapstick.com

    Paraben Free

  • PRINCIPAL DISPLAY PANEL

    BRAND LIP CARE

    ChapStick®

    EXTERNAL ANALGESIC | SKIN PROTECTANT

    CLASSIC
    MEDICATED

    SOOTHES, COOLS & PROTECTS TO
    RELIEVE SEVERELY DRY, CHAPPED LIPS

    NET WT 0.15 OZ (4 g)

    Principal Display Panel - 4 g Cylinder Blister Pack
  • INGREDIENTS AND APPEARANCE
    CHAPSTICK MEDICATED 
    camphor, menthol, petrolatum, phenol stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-0720
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10 mg  in 1 g
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM6 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM410 mg  in 1 g
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    Product Characteristics
    ColorYELLOWScore    
    ShapeBULLET (Cylindrical) Size42mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-0720-121 in 1 BLISTER PACK06/10/2018
    14 g in 1 CYLINDER; Type 0: Not a Combination Product
    2NDC:0573-0720-514 g in 1 CYLINDER; Type 0: Not a Combination Product06/10/2018
    3NDC:0573-0720-702 in 1 BLISTER PACK06/10/2018
    34 g in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/10/2018
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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