FDA.reportPublic FDA data

Chapstick

Manufacturer
GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Effective date
2021-03-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:39:29

Label at a glance#

ProductChapstick
Active ingredientPETROLATUM
Label structure5 sections

Label contents#

Full prescribing information#

ChapStick Mint Tea

SPL UNCLASSIFIED SECTION

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum 45%

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps prevent and temporarily protects chafed, chapped or cracked lips
  • helps prevent and protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only

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 as needed

Other information

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

arachidyl propionate, blue 1 lake, carnauba wax, cetyl alcohol, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, maltol, natural and artificial flavor, octyldodecanol, paraffin, phenyl trimethicone, saccharin, white wax, yellow 5 lake

Questions or comments?

OTC - QUESTIONS SECTION

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

ChapStick Rose Water

SPL UNCLASSIFIED SECTION

Ingredients

SPL UNCLASSIFIED SECTION

petrolatum, paraffin, mineral oil, octyldodecanol, bis-diglyceryl polyacyladipate-2, caprylic/capric triglyceride, arachidyl propionate, phenyl trimethicone, beeswax, copernicia cerifera (carnauba) wax, isopropyl myristate, cetyl alcohol, lecithin (soy), flavor, saccharin, lanolin, titanium dioxide, red 6 lake, yellow 6 lake, yellow 10 lake

Other information

OTHER SAFETY INFORMATION

store at 20-25°C (68-77°F)

Chapstick Almond Oil

SPL UNCLASSIFIED SECTION

Ingredients

SPL UNCLASSIFIED SECTION

petrolatum, paraffin, mineral oil, octyldodecanol, canola oil, bis-diglyceryl polyacyladipate-2, arachidyl propionate, phenyl trimethicone, beeswax, copernicia cerifera (carnauba) wax, isopropyl myristate, cetyl alcohol, lecithin (soy), titanium dioxide, synthetic wax, flavor, saccharin, iron oxides, isopropyl titanium trisostearate, yellow 6 lake

Other information

OTHER SAFETY INFORMATION

store at 20-25°C (68-77°F)

Additional information

SPL UNCLASSIFIED SECTION

Paraben-Free

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

Trademarks owned or licensed by GSK

©2020 GSK or licensor

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0573-2062-01

ChapStick®

SPA Collection

a refreshing flavor experience for lips

1 Skin Protectant 2 Cosmetics ·3 Sticks NET WT 0.15 OZ (4 g) EACH

PAA159505

Chapstick Spa Collection 0.15oz (4 g)
Chapstick Spa Collection 0.15oz (4 g)

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-2062-012025-01-30C16284748780-12cef2736-9ac7-d83d-e063-dadaa90ab31fDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2061-01Chapstick4 g in 1 TUBESTICK1 g450 mg in 1g1
0573-2062-01Chapstick1 in 1 PACKAGEKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2061CHAPSTICK (WHITE PETROLATUM) KIT [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]1Unmatched20210406_f0adf4a4-c8db-47c7-b553-89331cfb9258.zip
0573-2062CHAPSTICK (WHITE PETROLATUM) KIT [GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS (US) LLC]1Legacy NDC, 2 package rows20210406_f0adf4a4-c8db-47c7-b553-89331cfb9258.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-20620573-2062-01
0573-20610573-2061-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 54 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
ARACHIDYL PROPIONATEQV5DAH3MSBIACT
FD&C BLUE NO. 1--ALUMINUM LAKEJ9EQA3S2JMIACT
CARNAUBA WAXR12CBM0EIZIACT
CETYL ALCOHOL936JST6JCNIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT
MALTOL3A9RD92BS4IACT
OCTYLDODECANOL461N1O614YIACT
PARAFFINI9O0E3H2ZEIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
SACCHARINFST467XS7DIACT
WHITE WAX7G1J5DA97FIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
ALUMINUM OXIDELMI26O6933IACT
PETROLATUM4T6H12BN9UINGR
PARAFFINI9O0E3H2ZEINGR
MINERAL OILT5L8T28FGPINGR
OCTYLDODECANOL461N1O614YINGR
BIS-DIGLYCERYL POLYACYLADIPATE-26L246LAM9TINGR
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UINGR
ARACHIDYL PROPIONATEQV5DAH3MSBINGR
PHENYL TRIMETHICONEDR0K5NOJ4RINGR
CARNAUBA WAXR12CBM0EIZINGR
ISOPROPYL MYRISTATE0RE8K4LNJSINGR
CETYL ALCOHOL936JST6JCNINGR
LECITHIN, SOYBEAN1DI56QDM62INGR
SACCHARINFST467XS7DINGR
LANOLIN7EV65EAW6HINGR
TITANIUM DIOXIDE15FIX9V2JPINGR
D&C RED NO. 6481744AI4OINGR
ALUMINUM OXIDELMI26O6933INGR
FD&C YELLOW NO. 6H77VEI93A8INGR
D&C YELLOW NO. 1035SW5USQ3GINGR
PETROLATUM4T6H12BN9UINGR
PARAFFINI9O0E3H2ZEINGR
MINERAL OILT5L8T28FGPINGR
OCTYLDODECANOL461N1O614YINGR
CANOLA OIL331KBJ17RKINGR

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
f0adf4a4-c8db-47c7-b553-89331cfb9258f0adf4a4-c8db-47c7-b553-89331cfb92582021-03-24WarningsExact identifier
spl id: f0adf4a4-c8db-47c7-b553-89331cfb9258
spl set id: f0adf4a4-c8db-47c7-b553-89331cfb9258

Reported adverse events (FAERS/openFDA)#

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