ECO LIPS MENTHOL MEDICATED LIP BALM- menthol stick

Eco Lips Menthol Medicated Lip Balm by

Drug Labeling and Warnings

Eco Lips Menthol Medicated Lip Balm by is a Otc medication manufactured, distributed, or labeled by Eco Lips, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT

Active Ingredient

Menthol 1%

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

When using this product avoid 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:

• 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.

QUESTIONS

Questions or Comments? Call 1-866-326-5477,

Monday-Friday, 8 a.m. to 5 p.m. CST

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ECO LIPS MENTHOL MEDICATED LIP BALM 
menthol stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75071-010
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75071-010-01	1 in 1 BOX	06/05/2023
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 not final	part348	06/05/2023

Labeler - Eco Lips, Inc. (138732727)

Establishment
Name	Address	ID/FEI	Business Operations
Eco Lips, Inc.		138732727	manufacture(75071-010)