FDA.reportPublic FDA data

Medicated Herbal Lip Balm

Manufacturer
Earth Mama Angel Baby LLC
Effective date
2024-10-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:22:20

Label at a glance#

ProductMedicated Herbal Lip Balm
Active ingredientMENTHOL
Label structure12 sections

Storage and handling

Other information protect from excessive heat and direct sunlight

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Menthol 1%

OTC - PURPOSE SECTION

Purpose

Fever blister / cold sore treatment

INDICATIONS & USAGE SECTION

UsesFor the temporary relief of pain and itching associated with fever blisters and

cold sores.

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this productavoid contact with eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DOSAGE & ADMINISTRATION SECTION

Directions

adults & children 2 years of age and older:

  • apply a small amount of product to affected area not more than 3 to 4 times daily
  • wash hands before and after applying balm
  • do not share product with anyone else

children under 2 years of age:ask a doctor

STORAGE AND HANDLING SECTION

Other informationprotect from excessive heat and direct sunlight

INACTIVE INGREDIENT SECTION

Inactive ingredients*Beeswax, *Calendula Flower Extract, *Chamomile Extract, *Cocoa Butter, *Coconut Oil, *Echinacea Root Extract, *Eucalyptus Oil, *Licorice Root Extract, *Lemon Balm Leaf Extract, *Peppermint Oil, *Rosemary Extract, *St John's Wort Extract, *Sunflower Oil, *Tea Tree Oil, Mixed Tocopherols. *Organic

OTC - QUESTIONS SECTION

Questions or Comments?Call 503-607-0607 Monday-Friday 7:30 a.m to 4 p.m. pacific

Carton Text

SPL UNCLASSIFIED SECTION

Herbal Fever Blister

& Cold Sore Treatment

earth

mama

ORGANICS

MEDICATED HERBAL

Lip Balm

Refreshing Menthol Mint

Net Wt 0.15 Oz (4.25 g)

100% PLASTIC FREE

Haven't got

time for

the pain?

Try this thoughtfully

formulated

medicated lip balm

for fever blisters

and cold sores.

FOR EVERYONE AND THEIR MOTHER

Distributed by Earth Mama Angel Baby LLC

9866 SE Empire Ct., Clackamas, OR 97015 USA

EarthMama.com

Certified Organic by Oregon Tilth

B10-521-00

With Organic echinacea root, licorice root, chamomile and more.

Label Text

SPL UNCLASSIFIED SECTION

earth mama

ORGANICS

MEDICATED HERBAL

Lip Balm

HERBAL FEVER BLISTER

& COLD SORE TREATMENT

Net Wt 0.15 Oz (4.25 g)

100% PLASTIC FREE

Distributed by Earth Mama Angel Baby LLC

9866 SE Empire Ct., Clackamas, OR 97015 USA

EarthMama.com

Certified Organic by Oregon Tilth

L10-521-00

Refreshing Menthol Mint

Carton Artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Earth Mama Medicated Herbal Lip Balm 0.15 oz (4.25 g) Carton ArtworkEarth Mama Medicated Herbal Lip Balm 0.15 oz (4.25 g) Carton Artwork

Label Artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Earth Mama Medicated Herbal Lip Balm 0.15 oz (4.25 g) Tube Label ArtworkEarth Mama Medicated Herbal Lip Balm 0.15 oz (4.25 g) Tube Label Artwork

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
418610menthol 1 % Topical OintmentPSN2
418610menthol 0.01 MG/MG Topical OintmentSCD2
418610menthol 1 % Topical OintmentSY2
418610menthol 1 % Topical StickSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72812-155-01Medicated Herbal Lip Balm4.25 g in 1 TUBESTICK4.252
72812-155-01Medicated Herbal Lip Balm1 in 1 BOXSTICK12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72812-155MEDICATED HERBAL LIP BALM (MENTHOL) STICK [EARTH MAMA ANGEL BABY LLC]2Current NDC, 2 package rows20241003_1cc2391e-6a7a-609c-e063-6394a90a6305.zip

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
72812-15572812-155-01

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
SUNFLOWER OIL3W1JG795YIIACT
TEA TREE OILVIF565UC2GIACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
COCOA BUTTER512OYT1CRRIACT
ROSEMARY OIL8LGU7VM393IACT
PEPPERMINT OILAV092KU4JHIACT
COCONUT OILQ9L0O73W7LIACT
TOCOPHEROLR0ZB2556P8IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
YELLOW WAX2ZA36H0S2VIACT
MELISSA OFFICINALIS LEAF OILPTP6R7263MIACT
EUCALYPTUS OIL2R04ONI662IACT
ECHINACEA ANGUSTIFOLIA ROOTD982V7VT3PIACT
ST. JOHN'S WORTUFH8805FKAIACT
LICORICE61ZBX54883IACT
MENTHOLL7T10EIP3AACTIB

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 Herbal Lip BalmMENTHOLEarth Mama Angel Baby LLC1cc2391e-6a7a-609c-e063-6394a90a63052024-10-01WarningsExact identifier
ndc (package): 72812-155-01
ndc (product): 72812-155
ndc11 (package): 72812015501
spl id: 236e3fe4-5274-f3a0-e063-6394a90a5089
spl set id: 1cc2391e-6a7a-609c-e063-6394a90a6305

Reported adverse events (FAERS/openFDA)#

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