FDA.reportPublic FDA data

Carmex Classic Lip Balm Medicated

Manufacturer
Carma Laboratories, Inc.
Effective date
2025-10-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:30:34

Label at a glance#

ProductCarmex Classic Lip Balm Medicated
Active ingredientCAMPHOR (SYNTHETIC), WHITE PETROLATUM
Label structure11 sections

Indications and uses

helps provide relief of symptoms of cold sores and dry lips

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 1.70%
White Petrolatum 45.30%

Purpose

OTC - PURPOSE SECTION

External Analgesic
Lip Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps provide relief of symptoms of cold sores and dry 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 to lips not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

lanolin, beeswax, cetyl esters, paraffinum liquidum, theobroma cacao seed butter, menthol, salicylic acid, phenol, vanillin, flavor

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum 41.25%

Purpose

OTC - PURPOSE SECTION

Lip Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps prevent, protect, and relieve chapped 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 as needed

Inactive ingredients

INACTIVE INGREDIENT SECTION

lanolin, theobroma cacao (cocoa) seed butter, euphorbia cerifera (candelilla) cera, limnanthes alba (meadowfoam) seed oil beeswax, cetyl esters, ozokerite, paraffin, camphor, menthol, salicylic acid, phenol, flavor, vanillin

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentPSN1
2475168camphor 0.017 MG/MG / petrolatum 0.453 MG/MG Topical OintmentSCD1
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130083078022440GTIN-13: 0083078022440
EAN-13: 0083078022440
GTIN-12: 083078022440
UPC-A: 083078022440
GTIN storage (14 digits): 00083078022440		Label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10210-0022-6Carmex Classic Lip Balm Medicated10 g in 1 TUBESALVE20 g1.7 g in 100g1
10210-0053-1Carmex Classic Lip Balm Medicated2 in 1 TRAYSALVE412.5 mg in 1g1
10210-0053-1Carmex Classic Lip Balm Medicated4.25 g in 1 CYLINDERSALVE8.5 g412.5 mg in 1g1
10210-0096-1Carmex Classic Lip Balm Medicated1 in 1 KITKIT11

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
10210-009610210-0096-1
10210-002210210-0022-6
10210-005310210-0053-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN7EV65EAW6HIACT
YELLOW WAX2ZA36H0S2VIACT
CETYL ESTERS WAXD072FFP9GUIACT
MINERAL OILT5L8T28FGPIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
SALICYLIC ACIDO414PZ4LPZIACT
PHENOL339NCG44TVIACT
VANILLINCHI530446XIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
WHITE PETROLATUMB6E5W8RQJ4ACTIB
LANOLIN7EV65EAW6HIACT
COCOA BUTTER512OYT1CRRIACT
CETYL ESTERS WAXD072FFP9GUIACT
PARAFFINI9O0E3H2ZEIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
MENTHOLL7T10EIP3AIACT
SALICYLIC ACIDO414PZ4LPZIACT
PHENOL339NCG44TVIACT
VANILLINCHI530446XIACT
WHITE PETROLATUMB6E5W8RQJ4ACTIB

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Carmex 10 count variety pack Lip BalmOCTINOXATE, OXYBENZONE, CAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.9c5168d5-31ed-4ce1-b16a-5f51f7e44ed22026-04-30WarningsExact identifier
ndc (package): 10210-0022-6
ndc11 (package): 10210002206
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), WHITE PETROLATUMCarma Laboratories, Inc.c7a7626c-cf82-4301-af79-c5e85367e7772025-10-01WarningsExact identifier
ndc (package): 10210-0096-1
ndc (package): 10210-0053-1
ndc (package): 10210-0022-6
ndc (product): 10210-0096
ndc11 (package): 10210009601
ndc11 (package): 10210005301
ndc11 (package): 10210002206
spl id: 401e3b66-8fa9-8de9-e063-6394a90a4a1e
spl set id: c7a7626c-cf82-4301-af79-c5e85367e777
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e572025-03-20WarningsExact identifier
ndc (package): 10210-0022-6
ndc (product): 10210-0022
ndc11 (package): 10210002206
Carmex Variety Pack Classic Medicated Lip Balm Daily Care Lip Balm SPFCAMPHOR (SYNTHETIC), WHITE PETROLATUM OCTINOXATE, OXYBENZONE, AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECarma Laboratories, Inc.5f904369-5f21-4907-98de-df23bce308232025-03-20WarningsExact identifier
ndc (package): 10210-0022-6
ndc11 (package): 10210002206
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.3a3af6e1-0281-462e-85e7-144cc5d46f322025-03-19WarningsExact identifier
ndc (package): 10210-0022-6
ndc11 (package): 10210002206
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.c04059e9-8175-46c2-8582-f84ef193abd32025-03-19WarningsExact identifier
ndc (package): 10210-0022-6
ndc11 (package): 10210002206
Carmex Variety Pack Classic Medicated Lip Balm Lip Balm SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.3a36a241-37a9-445a-a6e0-97709a7457a82025-03-19WarningsExact identifier
ndc (package): 10210-0022-6
ndc11 (package): 10210002206
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.0bc6812a-5c2a-7bb9-e063-6294a90a36e32023-12-05WarningsExact identifier
ndc (package): 10210-0022-6
ndc11 (package): 10210002206
Carmex Classic Lip Balm Medicated Free Strawberry Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONECarma Laboratories, Inc.34fae56e-367d-4659-af2d-1c9ddaf1639c2023-12-05WarningsExact identifier
ndc (package): 10210-0022-6
ndc11 (package): 10210002206
Carmex Classic Lip Balm Medicated Triple Force FormulaWHITE PETROLATUMCarma Laboratories, Inc.bc3fd42d-a03c-41a2-8239-f1c1e1d2a2d92023-11-06WarningsExact identifier
ndc (package): 10210-0053-1
ndc (product): 10210-0053
ndc11 (package): 10210005301
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.5378d653-702d-405c-a067-882554aaf93a2023-08-21WarningsExact identifier
ndc (package): 10210-0022-6
ndc11 (package): 10210002206

Reported adverse events (FAERS/openFDA)#

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