Eco Lips Menthol Medicated Lip Balm

Eco Lips Menthol Medicated Lip Balm
SPL v3
SPL
SPL Set ID fc4c25d6-6109-dfd8-e053-6394a90a4e91
Route
TOPICAL
Published
Effective Date 2025-09-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.0425 g)
Inactive Ingredients
Sunflower Oil Tea Tree Oil Chamomile Flower Oil Cocoa Butter Rosemary Oil Peppermint Oil Coconut Oil Tocopherol Calendula Officinalis Flower Yellow Wax Melissa Officinalis Leaf Oil Eucalyptus Oil Echinacea Angustifolia Root St. John's Wort Licorice

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-05

Description

Active Ingredient Menthol 1%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

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

Dosage and 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

Description

Active Ingredient Menthol 1%

Section 43683-2

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

Section 44425-7

Other information protect from excessive heat and direct sunlight

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9

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
Section 50567-7

When using this product avoid contact with eyes

Section 51727-6

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.

Section 53413-1

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

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

Section 55105-1

Purpose

Fever blister / cold sore treatment

Section 55106-9

Active Ingredient

Menthol 1%

Label Text

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 Text

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

Label Artwork

Carton Artwork


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 43683-2 (43683-2)

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

Section 44425-7 (44425-7)

Other information protect from excessive heat and direct sunlight

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 50566-9 (50566-9)

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
Section 50567-7 (50567-7)

When using this product avoid contact with eyes

Section 51727-6 (51727-6)

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.

Section 53413-1 (53413-1)

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

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

Section 55105-1 (55105-1)

Purpose

Fever blister / cold sore treatment

Section 55106-9 (55106-9)

Active Ingredient

Menthol 1%

Label Text (Label text)

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 Text

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

Label Artwork (Label artwork)

Carton Artwork


Advanced Ingredient Data


Raw Label Data

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