FDA.reportPublic FDA data

ChapStick Classic Medicated

Manufacturer
Suave Brands Co., LLC | Fareva Richmond Inc
Effective date
2026-03-31
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:52:06

Label at a glance#

ProductChapStick Classic Medicated
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Camphor

Menthol

White Petrolatum

Medicated Drug Fact BoxMedicated Drug Fact Box

INACTIVE INGREDIENT SECTION

Inactive Ingredients: arachidyl propionate, cetyl alcohol, Copernicia cerifera (carnauba) wax, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, Theobroma cacao (cocoa) seed butter, white wax

INDICATIONS & USAGE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Warnings

  • For external use only
  • When using this product avoid contact with the eyes
  • Stop use and ask a doctor if
    • Condition worsens
    • symptoms persist for more than 7 days or clear and ocur again within a few days
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - PURPOSE SECTION

Purpose

External analgesic

Skin Protectant

WARNINGS SECTION

Warnings

  • For external use only
  • When using this product avoid contact with the eyes
  • Stop use and ask a doctor if
  • Condition worsens
  • symptoms persist for more than 7 days or clear and ocur again within a few days
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children under 2 years or age and older:

apply to lips not more than 3 to 4 times daily

  • children under 2 years of age: ask doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.45 oz Long Card0.45 oz Long Card12 ct Refill BC Medicated12 ct Refill BC Medicated

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83711-809-47ChapStick Classic Medicated4 g in 1 APPLICATORSTICK47
83711-809-50ChapStick Classic Medicated4 g in 1 APPLICATORSTICK47
83711-809-51ChapStick Classic Medicated4 g in 1 APPLICATORSTICK47

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83711-80983711-809-50, 83711-809-51, 83711-809-47

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
COPERNICIA CERIFERA (CARNAUBA) WAXR12CBM0EIZIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
LIGHT MINERAL OILN6K5787QVPIACT
ISOPROPYL LAURATEU0JQ94LABMIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
LANOLIN7EV65EAW6HIACT
CETYL ALCOHOL936JST6JCNIACT
ARACHIDYL PROPIONATEQV5DAH3MSBIACT
PARAFFINI9O0E3H2ZEIACT
WHITE WAX7G1J5DA97FIACT
OCTYLDODECANOL461N1O614YIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
OLEYL ALCOHOL172F2WN8DVIACT
THEOBROMA CACAO (COCOA) SEED BUTTER512OYT1CRRIACT
FRAGRANCE 135765EM498GW35IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB

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
ChapStick Classic MedicatedEXTERNAL ANALGESIC AND SKIN PROTECTANT LIP BALMSuave Brands Co., LLC42798a6c-2d7e-80f6-e063-6294a90a105f2026-03-31WarningsExact identifier
ndc (package): 83711-809-50
ndc (package): 83711-809-47
ndc (package): 83711-809-51
ndc (product): 83711-809
ndc11 (package): 83711080950
ndc11 (package): 83711080951
ndc11 (package): 83711080947
spl id: 4e4ef8f1-df6f-a07c-e063-6394a90a4249
spl set id: 42798a6c-2d7e-80f6-e063-6294a90a105f

Reported adverse events (FAERS/openFDA)#

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