FDA.reportPublic FDA data

Carmex Classic Lip Balm Medicated Lip Protectant

Manufacturer
Carma Laboratories, Inc.
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:58:54

Label at a glance#

ProductCarmex Classic Lip Balm Medicated Lip Protectant
Active ingredientWHITE PETROLATUM
Label structure7 sections

Indications and uses

helps prevent, protect, and relieve chapped lips

Dosage and administration

apply as needed

Label contents#

Full prescribing information#

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

For external use only

When using this product:

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if:

OTC - STOP USE SECTION

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

Do not use

OTC - DO NOT USE SECTION

  • deep puncture wounds
  • serious burns
  • animal bites

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

SPL UNCLASSIFIED SECTION

  • this is a personal care item, and should be used by one individual only
  • protect this product from excessive heat and direct sun

Inactive Ingredients

INACTIVE INGREDIENT SECTION

lanolin, beeswax, cetyl esters, paraffin, theobroma cacao seed butter, camphor, menthol, salicylic acid, phenol, vanillin, flavor

Package Labeling:10210-0055-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label10Label10

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10210-0055-1Carmex Classic Lip Balm Medicated Lip Protectant7.5 g in 1 JARSALVE7.52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10210-0055CARMEX CLASSIC LIP BALM MEDICATED LIP PROTECTANT (WHITE PETROLATUM) SALVE [CARMA LABORATORIES, INC.]2Current NDC, 1 package rows20231106_2ae691ae-541c-4ec0-9a59-9e10b88664af.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10210-005510210-0055-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
LANOLIN7EV65EAW6HIACT
YELLOW WAX2ZA36H0S2VIACT
CETYL ESTERS WAXD072FFP9GUIACT
PARAFFINI9O0E3H2ZEIACT
COCOA BUTTER512OYT1CRRIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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): 10210-0055-1
ndc11 (package): 10210005501
Carmex Classic Lip Balm Medicated Lip ProtectantWHITE PETROLATUMCarma Laboratories, Inc.2ae691ae-541c-4ec0-9a59-9e10b88664af2023-11-06WarningsExact identifier
ndc (package): 10210-0055-1
ndc (product): 10210-0055
ndc11 (package): 10210005501
spl id: 0976085c-9b8a-3792-e063-6394a90a58c5
spl set id: 2ae691ae-541c-4ec0-9a59-9e10b88664af

Reported adverse events (FAERS/openFDA)#

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