Otc - Active Ingredient
Active Ingredients
Menthol 1%
Medicated Herbal Lip Balm Stick
FDA Label NDC 72812-155
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Earth Mama Angel Baby Llc for the product Medicated Herbal Lip Balm (NDC 72812-155). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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
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
* Please review the disclaimer below.
