Otc - Active Ingredient
Active Ingredient
Menthol 1%
Eco Lips Menthol Medicated Lip Balm Stick
FDA Label NDC 75071-010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Eco Lips, Inc. for the product Eco Lips Menthol Medicated Lip Balm (NDC 75071-010). 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
Uses soothes and protects painful fever blisters and cold sores.
Warnings
Warnings
For external use only
Otc - When Using
When using this product avoid 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:
- clean the affected area
- apply a small amount of product to affected area not more than 3 to 4 times daily
- rub in genlty; may be covered with a sterile bandage
- wash hands before and after applying balm
- do not share product with anyone else
children under 12 years of age: ask a doctor
Storage And Handling
Other information store at room temperature
Inactive Ingredient
Inactive ingredients *Beeswax, *Calendula Flower Extract, *Chamomile Extract, ⴕ*Cocoa Butter, ⴕ*Coconut Oil, *Echinacea Root Extract, *Eucalyptus Oil, *Licorice Root Extract, *Lemon Balm Leaf Extract, *Peppermint Oil, *Tea Tree Oil, Mixed Tocopherols. *Certified Organic Ingredient ⴕFair Trade Certified™ by Fair Trade USA.® 20% of Product.
Otc - Questions
Questions or Comments? Call 1-866-326-5477,
Monday-Friday, 8 a.m. to 5 p.m. CST
Other
Menthol Medicated Fever Blister/Cold Sore Treatment
Net Wt 0.15 Oz (4.25 g)
Certified Organic by Oregon Tilth
Manufactured in USA
PlantPod Plast Free Tube
Fast Relief of Itching & Pain
With Tea Tree, Lemon Balm & Peppermint
Soothe and protect painful fever blisters and cold sores with this special medicated lip care blend. Menthol and lemon balm work together providing a cool soothing effect to promote relief.
Eco Lips, Inc. Cedar Rapids, IA 52402
Ecolips.com
* Please review the disclaimer below.
