FDA.reportPublic FDA data

CHAPSTICK OVERNIGHT

Manufacturer
Pfizer Consumer Healthcare | Fareva Richmond, Inc.
Effective date
2011-12-14
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 01:49:56

Label at a glance#

ProductCHAPSTICK OVERNIGHT
Active ingredientdimethicone
Label structure9 sections

Indications and uses

helps prevent and temporarily protects chafed, chapped or cracked lips

Dosage and administration

apply liberally nightly

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 2%

PURPOSE

OTC - PURPOSE SECTION

Lip protectant

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • apply liberally nightly

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

  • store at 20-25°C (68-77°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

PRODUCT PACKAGING

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Lip Treatment Packaging
ChapStick Overnight Lip Treatment Packaging

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-1935-122021-05-05C16284748780-19d75b9d0-8830-f424-e053-dadaa90a57ceChapStick Overnight Lip Treatment (dimethicone)
0573-1935-122020-01-31C16284748780-19d75b9d0-8830-f424-e053-dadaa90a57ceChapStick Overnight Lip Treatment (dimethicone)

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
dimethiconeACTIVE INGREDIENT92RU3N3Y1O4
dimethiconeACTIVE MOIETY92RU3N3Y1O4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-19350573-1935-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
dimethicone92RU3N3Y1OACTIM
petrolatum4T6H12BN9UIACT
microcrystalline waxXOF597Q3KYIACT
cetyl alcohol936JST6JCNIACT
cyclomethiconeNMQ347994ZIACT
lactic acid33X04XA5ATIACT
aloe vera leafZY81Z83H0XIACT
silicon dioxideETJ7Z6XBU4IACT
methylparabenA2I8C7HI9TIACT
mineral oilT5L8T28FGPIACT
propylparabenZ8IX2SC1OHIACT
salicylic acidO414PZ4LPZIACT
vitamin a81G40H8B0TIACT
vitamin e acetate9E8X80D2L0IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
509b8ef4-bf7d-41ec-8093-ec0ac7ae3e51dc1436e4-c3d4-072e-0730-0f81e7458e262021-04-30WarningsExact identifier
spl set id: dc1436e4-c3d4-072e-0730-0f81e7458e26

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.