FDA Label for Medicated Herbal Lip Balm

View Indications, Usage & Precautions

OTC - ACTIVE INGREDIENT
OTC - PURPOSE
INDICATIONS & USAGE
WARNINGS
OTC - WHEN USING
OTC - STOP USE
OTC - KEEP OUT OF REACH OF CHILDREN
DOSAGE & ADMINISTRATION
STORAGE AND HANDLING
INACTIVE INGREDIENT
OTC - QUESTIONS
CARTON TEXT
LABEL TEXT
CARTON ARTWORK
LABEL ARTWORK

Medicated Herbal Lip Balm Product Label

The following document was submitted to the FDA by the labeler of this product Earth Mama Angel Baby Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient

Active Ingredients

Menthol 1%

Otc - 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

For external use only

Otc - When Using

When using this productavoid contact with eyes

Otc - Stop Use

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

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

Otc - 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