FDA.reportPublic FDA data

Carmex Moisturising Lip Balm

Manufacturer
Carma Laboratories, Inc.
Effective date
2020-02-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:28:14

Label at a glance#

ProductCarmex Moisturising Lip Balm
Active ingredientCAMPHOR (SYNTHETIC), PETROLATUM
Label structure8 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 46.16%

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

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 on:

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

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

petrolatum, lanolin, cera alba, cetyl esters, paraffin, theobroma cacao seed butter, camphor, menthol, salicylic acid, aroma, vanillin

Package Labeling: 10210-0026-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

Package Labeling: 10210-0026-2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package2Outer Package2Inner Package2Inner Package2

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10210-002610210-0026-1, 10210-0026-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
PARAFFINI9O0E3H2ZEIACT
LANOLIN7EV65EAW6HIACT
WHITE WAX7G1J5DA97FIACT
CETYL ESTERS WAXD072FFP9GUIACT
COCOA BUTTER512OYT1CRRIACT
MENTHOLL7T10EIP3AIACT
SALICYLIC ACIDO414PZ4LPZIACT
VANILLINCHI530446XIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
PETROLATUM4T6H12BN9UACTIB

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
b59827c4-2e2b-5a0d-e053-2a95a90aa8919dff2418-031e-1308-e053-2995a90accb42020-12-03WarningsExact identifier
spl set id: 9dff2418-031e-1308-e053-2995a90accb4

Reported adverse events (FAERS/openFDA)#

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