Chapstick 12 Days of Christmas: Package Insert and Label Information

CHAPSTICK 12 DAYS OF CHRISTMAS- white petrolatum
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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.

Classic Original | Cherry

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 (Classic Original)

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, red 6 lake, titanium dioxide, white wax, yellow 5 lake

Inactive ingredients (Classic Cherry)

arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, menthol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax

Questions or Comments?

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

Cosmetic Lip Balms

Ingredients (Clover Honey)

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), flavor, saccharin, synthetic wax, iron oxides, isopropyl titanium triisostearate

Ingredients (Cake Batter)

petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, caprylic/capric triglyceride, phenyl trimethicone, arachidyl propionate, beeswax, isopropyl myristate, copernicia cerifera (carnauba) wax, lecithin (soy), cetyl alcohol, flavor, triacetin, benzyl benzoate, saccharin, titanium dioxide, synthetic wax, isopropyl titanium triisostearate

Ingredients (Cotton Candy)

petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, arachidyl propionate, phenyl trimethicone, beeswax, benzyl benzoate, copernicia cerifera (carnauba) wax, isopropyl myristate, cetyl alcohol, lecithin (soy), flavor, saccharin, synthetic wax, blue 1 lake, isopropyl titanium triisostearate

Ingredients (Passion Fruit)

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

Ingredients (Holiday Cocoa)

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, synthetic wax, yellow 5 lake, blue 1 lake, isopropyl titanium triisostearate

Ingredients (Vanilla Latte)

petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, caprylic/capric triglyceride, phenyl trimethicone, arachidyl propionate, beeswax, copernicia cerifera (carnauba) wax, isopropyl myristate, cetyl alcohol, flavor, titanium dioxide, synthetic wax, saccharin, triacetin, iron

oxides, isopropyl titanium triisostearate

Ingredients (Pumpkin Pie)

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

Ingredients (Sugar Cookie)

petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, arachidyl propionate, phenyl trimethicone, beeswax, caprylic/capric triglyceride, flavor, copernicia cerifera (carnauba) wax, isopropyl myristate, cetyl alcohol, benzyl benzoate, triacetin, saccharin

Ingredients (Candy Cane)

petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, flavor, arachidyl propionate, phenyl trimethicone, beeswax, copernicia cerifera (carnauba) wax, isopropyl myristate, cetyl alcohol, titanium dioxide, synthetic wax, saccharin, canola oil, isopropyl titanium triisostearate

Ingredients (Vanilla Mint)

petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, caprylic/capric triglyceride, arachidyl propionate, phenyl trimethicone, beeswax, copernicia cerifera (carnauba) wax, isopropyl myristate, flavor, cetyl alcohol, lecithin (soy), ethyl alcohol, saccharin

Other Information

store at 20-25°C (68-77°F)

Additional Information

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

Trademarks owned or licensed by GSK

©2021 GSK or licensor

PRINCIPAL DISPLAY PANEL

NDC 0573-2028-01

12 days of

ChapStick®

to

from

1 Classic Original Skin Protectant
1 Classic Cherry Skin Protectant
10 Cosmetic Lip Balms

12 STICKS

NET WT 0.15 OZ

(4 g) EACH

000065947 – Front

Chapstick 12 Days of Christmas 12 ct
(click image for full-size original)
Established Pharmacological Class
Substance Pharmacological Class
ChapstickClover Honey Other Skin Care Preparations
ChapstickCake Batter Other Skin Care Preparations
ChapstickCotton Candy Other Skin Care Preparations
ChapstickPassion Fruit Other Skin Care Preparations
ChapstickHoliday Cocoa Other Skin Care Preparations
ChapstickVanilla Latte Other Skin Care Preparations
ChapstickPumpkin Pie Other Skin Care Preparations
ChapstickSugar Cookie Other Skin Care Preparations
ChapstickCandy Cane Other Skin Care Preparations
ChapstickVanilla Mint Other Skin Care Preparations
CHAPSTICK 12 DAYS OF CHRISTMAS
white petrolatum kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-2029
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0135-2029-01 1 KIT in 1 PACKAGE None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 CYLINDER 4 g
Part 2 1 CYLINDER 4 g
Part 3 1 CYLINDER 4 g
Part 4 1 CYLINDER 4 g
Part 5 1 CYLINDER 4 g
Part 6 1 CYLINDER 4 g
Part 7 1 CYLINDER 4 g
Part 8 1 CYLINDER 4 g
Part 9 4
Part 10 4
Part 11 1 CYLINDER 4 g
Part 12 1 CYLINDER 4 g
Part 1 of 12
CHAPSTICK CLASSIC ORIGINAL
white petrolatum stick
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 450 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CAMPHOR (NATURAL)
CARNAUBA WAX
CETYL ALCOHOL
ISOPROPYL MYRISTATE
LANOLIN
LIGHT MINERAL OIL
OCTYLDODECANOL
OLEYL ALCOHOL
PARAFFIN
PHENYL TRIMETHICONE
D&C RED NO. 6
TITANIUM DIOXIDE
WHITE WAX
FD&C YELLOW NO. 5
Product Characteristics
Color PINK Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 4 g in 1 CYLINDER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 09/30/2021
Part 2 of 12
CHAPSTICK CLASSIC CHERRY
white petrolatum stick
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PETROLATUM (PETROLATUM) PETROLATUM 450 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
ARACHIDYL PROPIONATE
CAMPHOR (NATURAL)
CARNAUBA WAX
CETYL ALCOHOL
ISOPROPYL MYRISTATE
LANOLIN
LIGHT MINERAL OIL
LEVOMENTHOL
OCTYLDODECANOL
PARAFFIN
PHENYL TRIMETHICONE
D&C RED NO. 6
SACCHARIN
WHITE WAX
Product Characteristics
Color PINK Score
Shape Size
Flavor CHERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 4 g in 1 CYLINDER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 09/30/2021
Part 3 of 12
CHAPSTICK CLOVER HONEY
cosmetic
Product Information
Route of Administration TOPICAL DEA Schedule
Packaging
# Item Code Package Description Multilevel Packaging
1 4 g in 1 CYLINDER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 09/30/2021
Part 4 of 12
CHAPSTICK CAKE BATTER
cosmetic
Product Information
Route of Administration TOPICAL DEA Schedule
Packaging
# Item Code Package Description Multilevel Packaging
1 4 g in 1 CYLINDER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 09/30/2021
Part 5 of 12
CHAPSTICK COTTON CANDY
cosmetic
Product Information
Route of Administration TOPICAL DEA Schedule
Packaging
# Item Code Package Description Multilevel Packaging
1 4 g in 1 CYLINDER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 09/30/2021
Part 6 of 12
CHAPSTICK PASSION FRUIT
cosmetic
Product Information
Route of Administration TOPICAL DEA Schedule
Packaging
# Item Code Package Description Multilevel Packaging
1 4 g in 1 CYLINDER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 09/30/2021
Part 7 of 12
CHAPSTICK HOLIDAY COCOA
cosmetic
Product Information
Route of Administration TOPICAL DEA Schedule
Packaging
# Item Code Package Description Multilevel Packaging
1 4 g in 1 CYLINDER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 09/30/2021
Part 8 of 12
CHAPSTICK VANILLA LATTE
cosmetic
Product Information
Route of Administration TOPICAL DEA Schedule
Packaging
# Item Code Package Description Multilevel Packaging
1 4 g in 1 CYLINDER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 09/30/2021
Part 9 of 12
CHAPSTICK PUMPKIN PIE
cosmetic
Product Information
Route of Administration TOPICAL DEA Schedule
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 09/30/2021
Part 10 of 12
CHAPSTICK SUGAR COOKIE
cosmetic
Product Information
Route of Administration TOPICAL DEA Schedule
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 09/30/2021
Part 11 of 12
CHAPSTICK CANDY CANE
cosmetic
Product Information
Route of Administration TOPICAL DEA Schedule
Packaging
# Item Code Package Description Multilevel Packaging
1 4 g in 1 CYLINDER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 09/30/2021
Part 12 of 12
CHAPSTICK VANILLA MINT
cosmetic
Product Information
Route of Administration TOPICAL DEA Schedule
Packaging
# Item Code Package Description Multilevel Packaging
1 4 g in 1 CYLINDER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Cosmetic 09/30/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 09/30/2021
Labeler — GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 09/2021 GlaxoSmithKline Consumer Healthcare Holdings (US) LLC

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