FDA.reportPublic FDA data

Eco Lips Menthol Medicated Lip Balm

Manufacturer
Eco Lips, Inc.
Effective date
2025-09-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:13:27

Label at a glance#

ProductEco Lips Menthol Medicated Lip Balm
Active ingredientMENTHOL
Label structure13 sections

Storage and handling

Other information protect from excessive heat and direct sunlight

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Menthol 1%

OTC - PURPOSE SECTION

Purpose

Fever blister / cold sore treatment

INDICATIONS & USAGE SECTION

Uses For the temporary relief of pain and itching associated with fever blisters and cold sores.

WARNINGS SECTION

Warnings

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes

OTC - STOP USE SECTION

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 SECTION

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 SECTION

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 SECTION

Other information protect from excessive heat and direct sunlight

INACTIVE INGREDIENT SECTION

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 SECTION

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

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

Carton Text

SPL UNCLASSIFIED SECTION

ECO LIPS

PLANTPOD

PLASTIC FREE TUBE

MENTHOL

MEDICATED

FEVER BLISTER/COLD SORE

TREATMENT

FAST RELIEF

OF ITCHING & PAIN

WITH TEA TREE,

LEMON BALM &

PEPPERMINT

Soothe painful and itchy

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.

Net Wt. .15 Oz (4.25 g)

ECO LIPS, INC. | CEDAR RAPIDS, IA 52402

ECOLIPS.COM

CERTIFIED ORGANIC BY OREGON TILTH

MANUFACTURED IN USA WITH

DOMESTIC AND IMPORTED COMPONENTS

100% PLASTIC FREE

SPREAD THE GOOD

RECENT MAJOR CHANGES SECTION

The following updates were incorporated into the product labeling beginning 7/2024

Uses For the temporary relief of pain and itching associated with fever blisters and cold sores.

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

Label text

SPL UNCLASSIFIED SECTION

ECO LIPS

MENTHOL

MEDICATED

FEVER BLISTER/COLD SORE

TREATMENT

WITH TEA TREEE,

LEMON BALM & PEPPERMINT

PLANTPOD

PLASTIC FREE TUBE

Net Wt. 0.15 oz (4.25g)

ECO LIPS, INC. | CEDAR RAPIDS, IA 52402 | ECOLIPS.COM

CERTIFIED ORGANIC BY OREGON TILTH

MANUFACTURED IN USA WITH

DOMESTIC AND IMPORTED COMPONENTS

Peel here for drug facts

Carton Artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eco Lips Medicated Cold Sore and Fever Blister Treatment 0.15 oz Carton ArtworkEco Lips Medicated Cold Sore and Fever Blister Treatment 0.15 oz Carton Artwork

Label artwork

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eco Lips Menthol Medicated Fever Blister and Cold Sore Treatment Lip Balm Label Artwork 0.15 ozEco Lips Menthol Medicated Fever Blister and Cold Sore Treatment Lip Balm Label Artwork 0.15 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
418610menthol 1 % Topical OintmentPSN3
418610menthol 0.01 MG/MG Topical OintmentSCD3
418610menthol 1 % Topical OintmentSY3
418610menthol 1 % Topical StickSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75071-010-01Eco Lips Menthol Medicated Lip Balm4.25 g in 1 TUBESTICK4.253
75071-010-01Eco Lips Menthol Medicated Lip Balm1 in 1 BOXSTICK13

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75071-01075071-010-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUNFLOWER OIL3W1JG795YIIACT
TEA TREE OILVIF565UC2GIACT
CHAMOMILE FLOWER OIL60F80Z61A9IACT
COCOA BUTTER512OYT1CRRIACT
ROSEMARY OIL8LGU7VM393IACT
MENTHOLL7T10EIP3AACTIB
PEPPERMINT OILAV092KU4JHIACT
COCONUT OILQ9L0O73W7LIACT
TOCOPHEROLR0ZB2556P8IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
YELLOW WAX2ZA36H0S2VIACT
MELISSA OFFICINALIS LEAF OILPTP6R7263MIACT
EUCALYPTUS OIL2R04ONI662IACT
ECHINACEA ANGUSTIFOLIA ROOTD982V7VT3PIACT
ST. JOHN'S WORTUFH8805FKAIACT
LICORICE61ZBX54883IACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eco Lips Menthol Medicated Lip BalmMENTHOLEco Lips, Inc.fc4c25d6-6109-dfd8-e053-6394a90a4e912025-09-10WarningsExact identifier
ndc (package): 75071-010-01
ndc (product): 75071-010
ndc11 (package): 75071001001
spl id: 3e7651a4-8c8d-5282-e063-6294a90abd19
spl set id: fc4c25d6-6109-dfd8-e053-6394a90a4e91

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.