FDA.reportPublic FDA data

Carmex Classic Lip Balm Medicated

Manufacturer
Carma Laboratories, Inc.
Effective date
2025-03-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:57:32

Label at a glance#

ProductCarmex Classic Lip Balm Medicated
Active ingredientCAMPHOR (SYNTHETIC), WHITE PETROLATUM
Label structure9 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

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

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MedicatedMedicated

22

Package Labeling:10210-0022-7

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

Package Labeling: 10210-0022-8

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label boxLabel box

Inner labelInner label

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentPSN5
2475168camphor 0.017 MG/MG / petrolatum 0.453 MG/MG Topical OintmentSCD5
2475168camphor 1.7 % / petrolatum, white 45.3 % Topical OintmentSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10210-0022-1Carmex Classic Lip Balm Medicated1 in 1 BLISTER PACKSALVE15
10210-0022-1Carmex Classic Lip Balm Medicated7.5 g in 1 JARSALVE7.55
10210-0022-2Carmex Classic Lip Balm Medicated3 in 1 PACKAGESALVE35
10210-0022-2Carmex Classic Lip Balm Medicated7.5 g in 1 JARSALVE7.55
10210-0022-3Carmex Classic Lip Balm Medicated7.5 g in 1 JARSALVE7.55
10210-0022-4Carmex Classic Lip Balm Medicated10 g in 1 TUBESALVE105
10210-0022-4Carmex Classic Lip Balm Medicated1 in 1 BLISTER PACKSALVE15
10210-0022-5Carmex Classic Lip Balm Medicated3 in 1 PACKAGESALVE35
10210-0022-5Carmex Classic Lip Balm Medicated10 g in 1 TUBESALVE105
10210-0022-6Carmex Classic Lip Balm Medicated10 g in 1 TUBESALVE105
10210-0022-7Carmex Classic Lip Balm Medicated12 in 1 BOXSALVE125
10210-0022-7Carmex Classic Lip Balm Medicated10 g in 1 TUBESALVE105
10210-0022-8Carmex Classic Lip Balm Medicated10 g in 1 TUBESALVE105
10210-0022-8Carmex Classic Lip Balm Medicated2 in 1 BLISTER PACKSALVE25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10210-0022CARMEX CLASSIC LIP BALM MEDICATED (CAMPHOR (SYNTHETIC), PETROLATUM) SALVE [CARMA LABORATORIES, INC.]5Current NDC, Legacy NDC, 14 package rows20250322_fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e57.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
10210-002210210-0022-1, 10210-0022-2, 10210-0022-3, 10210-0022-4, 10210-0022-5, 10210-0022-6, 10210-0022-7, 10210-0022-8

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
CETYL ESTERS WAXD072FFP9GUIACT
COCOA BUTTER512OYT1CRRIACT
PARAFFINI9O0E3H2ZEIACT
YELLOW WAX2ZA36H0S2VIACT
MENTHOLL7T10EIP3AIACT
SALICYLIC ACIDO414PZ4LPZIACT
PHENOL339NCG44TVIACT
VANILLAQ74T35078HIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
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 · 10 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): 10210-0022-6
ndc11 (package): 10210002206
Carmex Classic Lip Balm MedicatedCAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e572025-03-20WarningsExact identifier
ndc (package): 10210-0022-3
ndc (package): 10210-0022-8
ndc (package): 10210-0022-5
ndc (package): 10210-0022-7
ndc (package): 10210-0022-2
ndc (package): 10210-0022-1
ndc (package): 10210-0022-4
ndc (package): 10210-0022-6
ndc (product): 10210-0022
ndc11 (package): 10210002202
ndc11 (package): 10210002205
ndc11 (package): 10210002203
ndc11 (package): 10210002201
ndc11 (package): 10210002208
ndc11 (package): 10210002207
ndc11 (package): 10210002204
ndc11 (package): 10210002206
spl id: 30cb63cc-47f3-ac7b-e063-6294a90abe38
spl set id: fb6eb93b-7dc0-4b6f-bfe1-1a7b47588e57
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 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.