FDA.reportPublic FDA data

ChapStick Classic Spearmint

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:10:02

Label at a glance#

ProductChapStick Classic Spearmint
Active ingredientPETROLATUM
Label structure9 sections

Storage and handling

Other Information store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

White Petrolatum 45%

OTC - PURPOSE SECTION

Purpose

Skin Protectant

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

For external use only

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

apply as needed

STORAGE AND HANDLING SECTION

Other Information

store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

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

OTC - QUESTIONS SECTION

Questions or Comments?

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

Additional information

SPL UNCLASSIFIED SECTION

Marketed by: Pfizer

Madison, NJ 07940 USA

©2018 Pfizer Inc.

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

Paraben Free

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BRAND LIP CARE
ChapStick®
SKIN PROTECTANT

CLASSIC
SPEARMINT

PROTECTS AND MOISTURIZES TO
HELP HEAL DRY, CHAPPED LIPS

NET WT 0.15 OZ (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack
PRINCIPAL DISPLAY PANEL - 4 g Cylinder Blister Pack

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-0711-122023-03-22C16284748780-1d6a99b39-989e-a426-e053-dadaa90af4c2Drug Facts
0573-0711-512023-03-22C16284748780-1d6a99b39-989e-a426-e053-dadaa90af4c2Drug Facts
0573-0711-122022-01-28C16284748780-1d6a99b39-989e-a426-e053-dadaa90af4c2Drug Facts
0573-0711-512022-01-28C16284748780-1d6a99b39-989e-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0711-12ChapStick Classic Spearmint4 g in 1 CYLINDERSTICK44
0573-0711-12ChapStick Classic Spearmint1 in 1 BLISTER PACKSTICK14
0573-0711-51ChapStick Classic Spearmint4 g in 1 CYLINDERSTICK44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0711CHAPSTICK CLASSIC SPEARMINT (WHITE PETROLATUM) STICK [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 3 package rows20240321_74354d8e-c265-4a27-9715-1a4c157ad890.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-07110573-0711-12, 0573-0711-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
ARACHIDYL PROPIONATEQV5DAH3MSBIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
CARNAUBA WAXR12CBM0EIZIACT
CETYL ALCOHOL936JST6JCNIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT
MALTOL3A9RD92BS4IACT
OCTYLDODECANOL461N1O614YIACT
PARAFFINI9O0E3H2ZEIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
SACCHARINFST467XS7DIACT
WHITE WAX7G1J5DA97FIACT
FD&C YELLOW NO. 5I753WB2F1MIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chapstick Holiday Classics KitWHITE PETROLATUMHaleon US Holdings LLC6df216dc-c03d-463a-8029-5e54c1dc3d272024-04-11WarningsExact identifier
ndc (package): 0573-0711-12
ndc11 (package): 00573071112
ChapStick Classic SpearmintWHITE PETROLATUMHaleon US Holdings LLC74354d8e-c265-4a27-9715-1a4c157ad8902024-03-19WarningsExact identifier
ndc (package): 0573-0711-12
ndc (package): 0573-0711-51
ndc (product): 0573-0711
ndc11 (package): 00573071151
ndc11 (package): 00573071112
spl id: f6c16211-6784-4ad4-96e3-5ef912bc376c
spl set id: 74354d8e-c265-4a27-9715-1a4c157ad890

Reported adverse events (FAERS/openFDA)#

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