RxNorm Names

Not yet provided

CHAPSTICK CLASSIC ORIGINAL (petrolatum) stick
[Pfizer Consumer Healthcare]

Permanent Link:

http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=2c3732ce-db6f-4d12-ac98-ecbe7ae0d0c2

Category	DEA Schedule	Marketing Status
HUMAN OTC DRUG LABEL		OTC monograph final

NOTE: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 Sections

Description
Clinical Pharmacology
Indications & Usage
Contraindications
Warnings
Precautions
Adverse Reactions
Overdosage
Dosage & Administration
How Supplied
Patient Counseling Information
Supplemental Patient Material
Boxed Warning
Patient Package Insert
Highlights
Full Table of Contents
Medication Guide

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

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)

PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack

CHAPSTICK CLASSIC ORIGINAL
petrolatum stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0573-1901
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
METHYLPARABEN
OCTYLDODECANOL
OLEYL ALCOHOL
PARAFFIN
PHENYL TRIMETHICONE
PROPYLPARABEN
D&C RED NO. 6
TITANIUM DIOXIDE
WHITE WAX
FD&C YELLOW NO. 5

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

Packaging
#	Item Code	Package Description
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)

Revised: 09/2012

Document Id: 4cf3a99e-92cc-444c-91f2-08d3cb2d8e3e

Set id: 2c3732ce-db6f-4d12-ac98-ecbe7ae0d0c2

Version: 1

Effective Time: 20120911

Pfizer Consumer Healthcare

Daily Med

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