Otc - Active Ingredient
Active Ingredients Menthol 1%
Earth Mama Medicated Herbal Lip Balm Stick
FDA Label NDC 79747-155
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eleeo Brands Llc for the product Earth Mama Medicated Herbal Lip Balm (NDC 79747-155). 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 - keep out of reach of children, dosage & administration, storage and handling, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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)
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
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
Otc - Questions
Questions or Comments?Cal 503-607-0607 Monday-Friday 7:30 a.m to 4 p.m. pacific
Other
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
* Please review the disclaimer below.
