EARTH MAMA MEDICATED HERBAL LIP BALM- menthol stick

Earth Mama Medicated Herbal Lip Balm by

Drug Labeling and Warnings

Earth Mama Medicated Herbal Lip Balm by is a Otc medication manufactured, distributed, or labeled by Eleeo Brands LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Menthol 1%

PURPOSE

Fever blister / cold sore treatment

INDICATIONS & USAGE

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

WARNINGS

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)

KEEP OUT OF REACH OF CHILDREN

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

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

Other informationprotect from excessive heat and direct sunlight

INACTIVE INGREDIENT

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

EARTH MAMA MEDICATED HERBAL LIP BALM 
menthol stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79747-155
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.0425 g  in 4.25 g

Inactive Ingredients
Ingredient Name	Strength
BEESWAX (UNII: 2ZA36H0S2V)
EUCALYPTUS OIL (UNII: 2R04ONI662)
COCONUT OIL (UNII: Q9L0O73W7L)
COCOA BUTTER (UNII: 512OYT1CRR)
ROSEMARY OIL (UNII: 8LGU7VM393)
LICORICE (UNII: 61ZBX54883)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
PEPPERMINT OIL (UNII: AV092KU4JH)
LEMON BALM OIL (UNII: MJ76269K9S)
TOCOPHEROL (UNII: R0ZB2556P8)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ST. JOHN'S WORT (UNII: UFH8805FKA)
TEA TREE OIL (UNII: VIF565UC2G)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79747-155-01	1 in 1 CARTON	01/01/2025
1		4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/01/2025

Labeler - Eleeo Brands LLC (078476782)