MEDICATED HERBAL LIP BALM- menthol stick

Medicated Herbal Lip Balm by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active Ingredients

Menthol 1%

PURPOSE

Purpose

Fever blister / cold sore treatment

INDICATIONS & USAGE

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

cold sores.

WARNINGS

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 swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

DOSAGE & ADMINISTRATION

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

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

Carton Text

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

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

Label Artwork

INGREDIENTS AND APPEARANCE

MEDICATED HERBAL LIP BALM 
menthol stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72812-155
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
SUNFLOWER OIL (UNII: 3W1JG795YI)
TEA TREE OIL (UNII: VIF565UC2G)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
COCOA BUTTER (UNII: 512OYT1CRR)
ROSEMARY OIL (UNII: 8LGU7VM393)
PEPPERMINT OIL (UNII: AV092KU4JH)
COCONUT OIL (UNII: Q9L0O73W7L)
TOCOPHEROL (UNII: R0ZB2556P8)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
YELLOW WAX (UNII: 2ZA36H0S2V)
MELISSA OFFICINALIS LEAF OIL (UNII: PTP6R7263M)
EUCALYPTUS OIL (UNII: 2R04ONI662)
ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P)
ST. JOHN'S WORT (UNII: UFH8805FKA)
LICORICE (UNII: 61ZBX54883)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT (Refreshing Menthol Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72812-155-01	1 in 1 BOX	07/10/2024
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	07/10/2024

Labeler - Earth Mama Angel Baby LLC (603560686)