CHAPSTICK OVERNIGHT

Dosage form: gel
Ingredients: dimethicone 20mg in 1g
Labeler: Pfizer Consumer Healthcare
NDC Code: 0573-1935

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.

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

©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.

CHAPSTICK OVERNIGHT 
dimethicone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0573-1935
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
dimethicone (dimethicone) dimethicone20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
petrolatum 
microcrystalline wax 
cetyl alcohol 
cyclomethicone 
lactic acid 
aloe vera leaf 
silicon dioxide 
methylparaben 
mineral oil 
propylparaben 
salicylic acid 
vitamin a 
vitamin e acetate 
Product Characteristics
ColorWHITE (opaque white to yellowish white) Score    
ShapeFREEFORM (jelly) Size1mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0573-1935-121 TUBE (TUBE) in 1 BLISTER PACK
17 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2004
Labeler - Pfizer Consumer Healthcare (828831730)
Establishment
NameAddressID/FEIOperations
Fareva Richmond, Inc.969523245ANALYSIS, LABEL, MANUFACTURE, PACK, RELABEL, REPACK

Revised: 12/2011
 
Pfizer Consumer Healthcare

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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