FDA.reportPublic FDA data

MEDICATED LIP BALM

Manufacturer
Burt's Bees, Inc.
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:57:55

Label at a glance#

ProductMEDICATED LIP BALM
Active ingredientMENTHOL
Label structure8 sections

Indications and uses

FOR THE TEMPORARY RELIEF OF PAIN AND ITCHING ASSOCIATED WITH FEVER BLISTERS AND COLD SORES

Dosage and administration

ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY. CHILDREN UNDER 2 YEARS OF AGE: CONSULT A DOCTOR.

Storage and handling

STORE AT ROOM TEMPERATURE

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

MENTHOL 0.9%

PURPOSE

OTC - PURPOSE SECTION

EXTERNAL ANALGESIC

USES

INDICATIONS & USAGE SECTION

FOR THE TEMPORARY RELIEF OF PAIN AND ITCHING ASSOCIATED WITH FEVER BLISTERS AND COLD SORES

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

IF CONDITION WORSENS OR IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS, DISCONTINUE USE AND CONSULT A DOCTOR.

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

AVOID CONTACT WITH EYES

KEEP OUT OF REACH OF CHUILDREN

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

ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER: APPLY TO AFFECTED AREA NOT MORE THAN 3 TO 4 TIMES DAILY.

CHILDREN UNDER 2 YEARS OF AGE: CONSULT A DOCTOR.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL, BEESWAX, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, RICINUS COMMUNIS (CASTOR) SEED OIL, EUPHORBIA CERIFERA WAX, EUCALYPTUS GLOBULUS LEAF OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, LANOLIN, CANOLA OIL, COPERNICA CERIFERA WAX, CITRIC ACID, GLYCINE SOJA (SOYBEAN) OIL, MELALEUCA ALTEMIFOLIA (TEA TREE) LEAF OIL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, TOCOPHEROL, LIMONENE, LINALOOL.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

STORE AT ROOM TEMPERATURE

PDP

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BURTS BEES

MEDICATED

LIP BALM WITH MENTHOL AND EUCALYPTUS

medicated lip balmmedicated lip balm

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
26052-029-01MEDICATED LIP BALM4.25 g in 1 TUBESTICK4.254
26052-029-02MEDICATED LIP BALM1 in 1 CARTONSTICK14
26052-029-03MEDICATED LIP BALM2 in 1 CARTONSTICK24
26052-029-03MEDICATED LIP BALM4.25 g in 1 TUBESTICK4.254
26052-029-04MEDICATED LIP BALM4.25 g in 1 TUBESTICK4.254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
26052-029MEDICATED LIP BALM (MENTHOL AND EUCALYPTUS) STICK [BURT'S BEES, INC.]4Current NDC, Legacy NDC, 5 package rows20181222_30da3cc5-6140-2dee-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
26052-02926052-029-01, 26052-029-02, 26052-029-03, 26052-029-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SUNFLOWER OIL3W1JG795YIIACT
WHITE WAX7G1J5DA97FIACT
EUCALYPTUS OIL2R04ONI662IACT
SHEA BUTTERK49155WL9YIACT
LANOLIN7EV65EAW6HIACT
CASTOR OILD5340Y2I9GIACT
CARNAUBA WAXR12CBM0EIZIACT
TEA TREE OILVIF565UC2GIACT
MENTHOLL7T10EIP3AACTIB
CANDELILLA WAXWL0328HX19IACT
SAFFLOWER OIL65UEH262ISIACT
CANOLA OIL331KBJ17RKIACT
SOYBEAN OIL241ATL177AIACT
ROSMARINUS OFFICINALIS FLOWERING TOP8JM482TI79IACT
TOCOPHEROLR0ZB2556P8IACT

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
MEDICATED LIP BALMMENTHOL AND EUCALYPTUSBurt's Bees, Inc.30da3cc5-6140-2dee-e054-00144ff8d46c2018-12-21WarningsExact identifier
ndc (package): 26052-029-02
ndc (package): 26052-029-01
ndc (package): 26052-029-03
ndc (package): 26052-029-04
ndc (product): 26052-029
ndc11 (package): 26052002903
ndc11 (package): 26052002904
ndc11 (package): 26052002901
ndc11 (package): 26052002902
spl id: 7d8cda7b-4881-6d66-e053-2991aa0ab3ee
spl set id: 30da3cc5-6140-2dee-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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