Label: CHAPSTICK CLASSIC SPEARMINT- petrolatum stick

  • NDC Code(s): 0573-1912-12, 0573-1912-24, 0573-1912-50
  • Packager: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
  • 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 November 30, 2020

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  • Active ingredient

    White Petrolatum 45%

  • Purpose

    Skin Protectant

  • Uses

    •
    helps prevent and temporarily protects chafed, chapped or cracked lips
    •
    helps prevent and protect from the drying effects of wind and cold weather
  • Warnings

    For external use only

    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

    store at 20-25°C (68-77°F)

  • Inactive ingredients

    arachidyl propionate, blue 1 lake, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, maltol, menthol, methylparaben, octyldodecanol, paraffin, phenyl trimethicone, propylparaben, saccharin, spearmint oil, white wax, yellow 5 lake

  • Questions or Comments?

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

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

  • PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack

    BRAND LIP CARE
    ChapStick®
    SKIN PROTECTANT

    CLASSIC
    SPEARMINT

    PROTECTS AND MOISTURIZES TO
    HELP HEAL DRY, CHAPPED LIPS

    NET WT 0.15 OZ (4 g)

    PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack
  • INGREDIENTS AND APPEARANCE
    CHAPSTICK CLASSIC SPEARMINT 
    petrolatum stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-1912
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM450 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MALTOL (UNII: 3A9RD92BS4)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SACCHARIN (UNII: FST467XS7D)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Product Characteristics
    ColorGREENScore    
    ShapeBULLETSize42mm
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-1912-121 in 1 BLISTER PACK08/01/2012
    14 g in 1 CYLINDER; Type 0: Not a Combination Product
    2NDC:0573-1912-241 in 1 BLISTER PACK08/01/2012
    24 g in 1 CYLINDER; Type 0: Not a Combination Product
    3NDC:0573-1912-504 g in 1 CYLINDER; Type 0: Not a Combination Product08/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/01/2012
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fareva Richmond, Inc.969523245ANALYSIS(0573-1912) , LABEL(0573-1912) , MANUFACTURE(0573-1912) , PACK(0573-1912) , RELABEL(0573-1912) , REPACK(0573-1912)
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