CHAPSTICK OVERNIGHT- dimethicone gel

CHAPSTICK OVERNIGHT by

Drug Labeling and Warnings

CHAPSTICK OVERNIGHT 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]

DRUG FACTS

ACTIVE INGREDIENT

Dimethicone 2%

PURPOSE

Lip protectant

USES

• helps prevent and temporarily protects chafed, chapped or cracked lips

WARNINGS

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

• apply liberally nightly

OTHER INFORMATION

• store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

white petrolatum, microcrystalline wax, isocetyl stearate, hydrogenated polyisobutene, cetyl alcohol, cyclomethicone, lactic acid. Contains 1% or less of: aloe barbadensis leaf extract, colloidal silicon dioxide, methylparaben, mineral oil, propylparaben, salicylic acid, vitamin A, vitamin E acetate.

QUESTIONS OR COMMENTS?

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

PRODUCT PACKAGING

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

ChapStick Overnight Lip Treatment

Dimethicone/Lip Protectant

Angled Tip

Glides on Easily

Contains 8 Different Moisturizers

Nourishes & Conditions Lips with a Long-Lasting Nightly Moisture Treatment

NET WT 0.25 OZ (7 g)

Pfizer, Madison, NJ 07940 USA

©2010 Pfizer Inc.

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

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin’s sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen and limit sun exposure while using this product and for a week afterwards.

INGREDIENTS AND APPEARANCE

CHAPSTICK OVERNIGHT 
dimethicone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0573-1935
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
dimethicone (UNII: 92RU3N3Y1O) (dimethicone - UNII:92RU3N3Y1O)	dimethicone	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
petrolatum (UNII: 4T6H12BN9U)
microcrystalline wax (UNII: XOF597Q3KY)
cetyl alcohol (UNII: 936JST6JCN)
cyclomethicone (UNII: NMQ347994Z)
lactic acid (UNII: 33X04XA5AT)
aloe vera leaf (UNII: ZY81Z83H0X)
silicon dioxide (UNII: ETJ7Z6XBU4)
methylparaben (UNII: A2I8C7HI9T)
mineral oil (UNII: T5L8T28FGP)
propylparaben (UNII: Z8IX2SC1OH)
salicylic acid (UNII: O414PZ4LPZ)
vitamin a (UNII: 81G40H8B0T)
vitamin e acetate (UNII: 9E8X80D2L0)

Product Characteristics
Color	WHITE (opaque white to yellowish white)	Score
Shape	FREEFORM (jelly)	Size	1mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0573-1935-12	1 in 1 BLISTER PACK
1		7 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	01/01/2004

Labeler - Pfizer Consumer Healthcare (828831730)

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