CHAPSTICK CLASSIC ORIGINAL- petrolatum stick

ChapStick Classic Original by

Drug Labeling and Warnings

ChapStick Classic Original by is a Otc medication manufactured, distributed, or labeled by Pfizer Consumer Healthcare, Fareva Richmond, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, methylparaben, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, propylparaben, red 6 lake, titanium dioxide, 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

SPL UNCLASSIFIED SECTION

Marketed by: Pfizer, Madison, NJ 07940 USA

PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack

BRAND LIP CARE
ChapStick®
SKIN PROTECTANT

CLASSIC
ORIGINAL

PROTECTS AND MOISTURIZES TO
HELP HEAL DRY, CHAPPED LIPS

NET WT 0.15 OZ (4 g)

INGREDIENTS AND APPEARANCE

CHAPSTICK CLASSIC ORIGINAL 
petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-1901
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	450 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
CAMPHOR (NATURAL) (UNII: N20HL7Q941)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CETYL ALCOHOL (UNII: 936JST6JCN)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LANOLIN (UNII: 7EV65EAW6H)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
METHYLPARABEN (UNII: A2I8C7HI9T)
OCTYLDODECANOL (UNII: 461N1O614Y)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
PARAFFIN (UNII: I9O0E3H2ZE)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
D&C RED NO. 6 (UNII: 481744AI4O)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WHITE WAX (UNII: 7G1J5DA97F)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Characteristics
Color	PINK	Score
Shape	BULLET	Size	42mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-1901-12	1 in 1 BLISTER PACK
1		4 g in 1 CYLINDER
2	NDC: 0573-1901-24	1 in 1 BLISTER PACK
2		4 g in 1 CYLINDER
3	NDC: 0573-1901-30	3 in 1 BLISTER PACK
3		4 g in 1 CYLINDER
4	NDC: 0573-1901-51	4 g in 1 CYLINDER
5	NDC: 0573-1901-50	4 g in 1 CYLINDER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	08/01/2012

Labeler - Pfizer Consumer Healthcare (828831730)

Establishment
Name	Address	ID/FEI	Business Operations
Fareva Richmond, Inc.		969523245	ANALYSIS(0573-1901) , LABEL(0573-1901) , MANUFACTURE(0573-1901) , PACK(0573-1901) , RELABEL(0573-1901) , REPACK(0573-1901)