FDA.reportPublic FDA data

CHAPSTICK MEDICATED

Manufacturer
Haleon US Holdings LLC
Effective date
2024-01-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:43

Label at a glance#

ProductCHAPSTICK MEDICATED
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, PETROLATUM, PHENOL
Label structure9 sections

Indications and uses

helps prevent and temporarily protects chafed, chapped or cracked lips temporary relief of pain associated with fever blisters and cold sores helps prevent and protect from the drying effects of wind and cold weather

Dosage and administration

adults and children 2 years of age and older: apply to lips not more than 3 to 4 times daily children under 2 years of age: ask a doctor

Storage and handling

store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphor 1%

Menthol 0.6%

Petrolatum 41%

Phenol 0.5%

Purposes

OTC - PURPOSE SECTION

External analgesic

External analgesic

Skin protectant

External analgesic

Uses

INDICATIONS & USAGE SECTION

  • helps prevent and temporarily protects chafed, chapped or cracked lips
  • temporary relief of pain associated with fever blisters and cold sores
  • helps prevent and protect from the drying effects of wind and cold weather

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this productavoid contact with the eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older: apply to lips not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

arachidyl propionate, carnauba wax, cetyl alcohol, cocoa butter, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, white wax

Questions or comments?

OTC - QUESTIONS SECTION

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

Additional information

SPL UNCLASSIFIED SECTION

Marketed by: Pfizer

Madison, NJ 07940 USA

© 2017 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 ®

EXTERNAL ANALGESIC | SKIN PROTECTANT

CLASSIC
MEDICATED

SOOTHES, COOLS & PROTECTS TO
RELIEVE SEVERELY 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
0573-0720-122024-07-30C16284748780-1d6a99b39-6588-a426-e053-dadaa90af4c2Drug Facts
0573-0720-512024-07-30C16284748780-1d6a99b39-6588-a426-e053-dadaa90af4c2Drug Facts
0573-0720-702024-07-30C16284748780-1d6a99b39-6588-a426-e053-dadaa90af4c2Drug Facts
0573-0720-122024-01-23C16284748780-1d6a99b39-6588-a426-e053-dadaa90af4c2Drug Facts
0573-0720-512024-01-23C16284748780-1d6a99b39-6588-a426-e053-dadaa90af4c2Drug Facts
0573-0720-702024-01-23C16284748780-1d6a99b39-6588-a426-e053-dadaa90af4c2Drug Facts
0573-0720-122022-01-28C16284748780-1d6a99b39-6588-a426-e053-dadaa90af4c2Drug Facts
0573-0720-512022-01-28C16284748780-1d6a99b39-6588-a426-e053-dadaa90af4c2Drug Facts
0573-0720-702022-01-28C16284748780-1d6a99b39-6588-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0720-12CHAPSTICK MEDICATED1 in 1 BLISTER PACKSTICK13
0573-0720-12CHAPSTICK MEDICATED4 g in 1 CYLINDERSTICK43
0573-0720-51CHAPSTICK MEDICATED4 g in 1 CYLINDERSTICK43
0573-0720-70CHAPSTICK MEDICATED2 in 1 BLISTER PACKSTICK23
0573-0720-70CHAPSTICK MEDICATED4 g in 1 CYLINDERSTICK43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0720CHAPSTICK MEDICATED (CAMPHOR, MENTHOL, PETROLATUM, PHENOL) STICK [HALEON US HOLDINGS LLC]3Legacy NDC, 5 package rows20240124_0c2ef605-26b6-4032-bdee-ce7583b04d46.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0720-12GM - Gram0573-0720b86bfd53-4314-4082-83f6-a86ee2734d3612022-12-07

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-07200573-0720-12, 0573-0720-51, 0573-0720-70

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARACHIDYL PROPIONATEQV5DAH3MSBIACT
CARNAUBA WAXR12CBM0EIZIACT
CETYL ALCOHOL936JST6JCNIACT
COCOA BUTTER512OYT1CRRIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT
OCTYLDODECANOL461N1O614YIACT
OLEYL ALCOHOL172F2WN8DVIACT
PARAFFINI9O0E3H2ZEIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
WHITE WAX7G1J5DA97FIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
PETROLATUM4T6H12BN9UACTIB
PHENOL339NCG44TVACTIB

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
0fa46f7f-0283-d223-e063-6294a90a3aff0c2ef605-26b6-4032-bdee-ce7583b04d462024-01-23WarningsExact identifier
spl id: 0fa46f7f-0283-d223-e063-6294a90a3aff
spl set id: 0c2ef605-26b6-4032-bdee-ce7583b04d46

Reported adverse events (FAERS/openFDA)#

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