CHAPSTICK OVERNIGHT- dimethicone gel
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.

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ChapStick Overnight Lip Treatment (dimethicone)

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

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.

ChapStick Overnight Lip Treatment Packaging

CHAPSTICK OVERNIGHT
dimethicone gel

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

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

Ingredient Name	Strength
Inactive Ingredients
petrolatum (UNII: 4T6H12BN9U)
microcrystalline wax (UNII: XOF597Q3KY)
cetyl alcohol (UNII: 936JST6JCN)
cyclomethicone (UNII: NMQ347994Z)
LACTIC ACID, UNSPECIFIED FORM (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)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0573-1935-12	1 in 1 BLISTER PACK	01/01/2004	08/31/2016
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	01/01/2004	08/31/2016

Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (079944263)

Revised: 4/2021

Document Id: 509b8ef4-bf7d-41ec-8093-ec0ac7ae3e51

Set id: dc1436e4-c3d4-072e-0730-0f81e7458e26

Version: 5

Effective Time: 20210430

GlaxoSmithKline Consumer Healthcare Holdings (US) LLC