Label: CHAPSTICK- white petrolatum kit

  • 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 March 24, 2021

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  • ChapStick Mint Tea

    Active Ingredients

    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, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, maltol, natural and artificial flavor, octyldodecanol, paraffin, phenyl trimethicone, saccharin, white wax, yellow 5 lake

    Questions or comments?

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

  • ChapStick Rose Water

    Ingredients

    petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, caprylic/capric triglyceride, arachidyl propionate, phenyl trimethicone, beeswax, copernicia cerifera (carnauba) wax, isopropyl myristate, cetyl alcohol, lecithin (soy), flavor, saccharin, lanolin, titanium dioxide, red 6 lake, yellow 6 lake, yellow 10 lake

    Other information

    store at 20-25°C (68-77°F)

  • Chapstick Almond Oil

    Ingredients

    petrolatum, paraffin, mineral oil, octyldodecanol, canola oil, bis-diglyceryl polyacyladipate-2, arachidyl propionate, phenyl trimethicone, beeswax, copernicia cerifera (carnauba) wax, isopropyl myristate, cetyl alcohol, lecithin (soy), titanium dioxide, synthetic wax, flavor, saccharin, iron oxides, isopropyl titanium trisostearate, yellow 6 lake

    Other information

    store at 20-25°C (68-77°F)

  • Additional information

    Paraben-Free

    Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

    Trademarks owned or licensed by GSK

    ©2020 GSK or licensor

  • Principal Display Panel

    0573-2062-01

    ChapStick®

    SPA Collection

    a refreshing flavor experience for lips

    1 Skin Protectant 2 Cosmetics ·3 Sticks NET WT 0.15 OZ (4 g) EACH

    PAA159505

    Chapstick Spa Collection 0.15oz (4 g)
  • INGREDIENTS AND APPEARANCE
    CHAPSTICK 
    white petrolatum kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-2062
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2062-011 in 1 PACKAGE; Type 0: Not a Combination Product03/28/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 TUBE 1 g
    Part 20 TUBE 1 g
    Part 30 TUBE 1 g
    Part 1 of 3
    CHAPSTICK MINT TEA 
    white petrolatum stick
    Product Information
    Item Code (Source)NDC:0573-2061
    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--ALUMINUM LAKE (UNII: J9EQA3S2JM)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    MALTOL (UNII: 3A9RD92BS4)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SACCHARIN (UNII: FST467XS7D)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorSPEARMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0573-2061-014 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/28/2021
    Part 2 of 3
    CHAPSTICK ROSE WATER 
    other skin care preparations
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRPETROLATUM (UNII: 4T6H12BN9U)  
    INGRPARAFFIN (UNII: I9O0E3H2ZE)  
    INGRMINERAL OIL (UNII: T5L8T28FGP)  
    INGROCTYLDODECANOL (UNII: 461N1O614Y)  
    INGRBIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    INGRARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)  
    INGRPHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    INGRCARNAUBA WAX (UNII: R12CBM0EIZ)  
    INGRISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRSACCHARIN (UNII: FST467XS7D)  
    INGRLANOLIN (UNII: 7EV65EAW6H)  
    INGRTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    INGRD&C RED NO. 6 (UNII: 481744AI4O)  
    INGRALUMINUM OXIDE (UNII: LMI26O6933)  
    INGRFD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    INGRD&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/28/2021
    Part 3 of 3
    CHAPSTICK ALMOND OIL 
    other skin care preparations
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRPETROLATUM (UNII: 4T6H12BN9U)  
    INGRPARAFFIN (UNII: I9O0E3H2ZE)  
    INGRMINERAL OIL (UNII: T5L8T28FGP)  
    INGROCTYLDODECANOL (UNII: 461N1O614Y)  
    INGRCANOLA OIL (UNII: 331KBJ17RK)  
    INGRBIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)  
    INGRARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)  
    INGRPHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    INGRCARNAUBA WAX (UNII: R12CBM0EIZ)  
    INGRISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRLECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    INGRTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    INGRSYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    INGRSACCHARIN (UNII: FST467XS7D)  
    INGRFERROUS OXIDE (UNII: G7036X8B5H)  
    INGRISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I)  
    INGRFD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    INGRALUMINUM OXIDE (UNII: LMI26O6933)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    14 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic03/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/28/2021
    Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)
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