FDA.reportPublic FDA data

Earth Mama Medicated Herbal Lip Balm

Manufacturer
Eleeo Brands LLC
Effective date
2025-08-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:10:35

Label at a glance#

ProductEarth Mama Medicated Herbal Lip Balm
Active ingredientMENTHOL
Label structure11 sections

Storage and handling

Other informationprotect from excessive heat and direct sunlight

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Menthol 1%

OTC - PURPOSE SECTION

Fever blister / cold sore treatment

INDICATIONS & USAGE SECTION

For the temporary relief of pain and itching associated with fever blisters and cold sores.

WARNINGS SECTION

For external use only When using this productavoid contact with eyes 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 Keep out of reach of children.If swalowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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

adults & children 2 years of age and older: apply a smal 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?Cal 503-607-0607 Monday-Friday 7:30 a.m to 4 p.m. pacific

SPL UNCLASSIFIED SECTION

Carton Text Herbal Fever Blister & Cold Sore Treatmentearth 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 thoughtfuly formulated medicated lip balm for fever blisters and cold sores. FOR EVERYONE AND THEIR MOTHER Distributed by Eleeo Brands LLC 2150 Winchell Ave. Cincinnati, OH 45214 USA EarthMama.com Certified Organic by Oregon Tilth B10-521-00 With Organic echinacea root, licorice root, chamomile and more.

Label Text earth mama ORGANICS MEDICATED HERBAL Lip Balm HERBAL FEVER BLISTER & COLD SORE TREATMENT Net Wt 0.15 Oz (4.25 g) 100% PLASTIC FREEDistributed by Eleeo Brands 2150 Winchell Ave. Cincinnati, OH 45214 USA EarthMama.com Certified Organic by Oregon Tilth L10-521-00 Refreshing Menthol Mint

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube LabelTube LabelCarton LabelCarton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
418610menthol 1 % Topical OintmentPSN1
418610menthol 0.01 MG/MG Topical OintmentSCD1
418610menthol 1 % Topical OintmentSY1
418610menthol 1 % Topical StickSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79747-155-01Earth Mama Medicated Herbal Lip Balm4.25 g in 1 TUBESTICK4.251
79747-155-01Earth Mama Medicated Herbal Lip Balm1 in 1 CARTONSTICK11

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
79747-15579747-155-01

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
BEESWAX2ZA36H0S2VIACT
EUCALYPTUS OIL2R04ONI662IACT
COCONUT OILQ9L0O73W7LIACT
COCOA BUTTER512OYT1CRRIACT
ROSEMARY OIL8LGU7VM393IACT
LICORICE61ZBX54883IACT
MENTHOLL7T10EIP3AACTIB
CHAMOMILE FLOWER OIL60F80Z61A9IACT
PEPPERMINT OILAV092KU4JHIACT
LEMON BALM OILMJ76269K9SIACT
TOCOPHEROLR0ZB2556P8IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
ST. JOHN'S WORTUFH8805FKAIACT
TEA TREE OILVIF565UC2GIACT
SUNFLOWER OIL3W1JG795YIIACT
ECHINACEA ANGUSTIFOLIA ROOTD982V7VT3PIACT

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
Earth Mama Medicated Herbal Lip BalmMENTHOLEleeo Brands LLC3c6c16bb-1f4b-b851-e063-6294a90a74042025-08-15WarningsExact identifier
ndc (package): 79747-155-01
ndc (product): 79747-155
ndc11 (package): 79747015501
spl id: 3c6c16bb-1f4c-b851-e063-6294a90a7404
spl set id: 3c6c16bb-1f4b-b851-e063-6294a90a7404

Reported adverse events (FAERS/openFDA)#

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