93760 Earth Mama Menthol Medicated Herbal Lip Balm

93760 Earth Mama Menthol Medicated Herbal Lip Balm
SPL v2
SPL
SPL Set ID 1cc2391e-6a7a-609c-e063-6394a90a6305
Route
TOPICAL
Published
Effective Date 2024-07-10
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 2024-07-10

Description

Active Ingredients 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 Ingredients Menthol 1%

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 productavoid contact with eyes

Section 51727-6

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

Section 53413-1

Questions or Comments? Call 503-607-0607 Monday-Friday 7:30 a.m to 4 p.m. pacific

Section 55105-1

Purpose

Fever blister / cold sore treatment

Section 55106-9

Active Ingredients

Menthol 1%

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 FREE

Distributed by Earth Mama Angel Baby LLC

9866 SE Empire Ct., Clackamas, OR 97015 USA

EarthMama.com

Certified Organic by Oregon Tilth

L10-521-00

Refreshing Menthol Mint

Carton Text

Herbal Fever Blister

& Cold Sore Treatment

earth

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 thoughtfully

formulated

medicated lip balm

for fever blisters

and cold sores.

FOR EVERYONE AND THEIR MOTHER

Distributed by Earth Mama Angel Baby LLC

9866 SE Empire Ct., Clackamas, OR 97015 USA

EarthMama.com

Certified Organic by Oregon Tilth

B10-521-00

With Organic echinacea root, licorice root, chamomile and more.

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 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 productavoid contact with eyes

Section 51727-6 (51727-6)

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

Section 53413-1 (53413-1)

Questions or Comments? Call 503-607-0607 Monday-Friday 7:30 a.m to 4 p.m. pacific

Section 55105-1 (55105-1)

Purpose

Fever blister / cold sore treatment

Section 55106-9 (55106-9)

Active Ingredients

Menthol 1%

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 FREE

Distributed by Earth Mama Angel Baby LLC

9866 SE Empire Ct., Clackamas, OR 97015 USA

EarthMama.com

Certified Organic by Oregon Tilth

L10-521-00

Refreshing Menthol Mint

Carton Text

Herbal Fever Blister

& Cold Sore Treatment

earth

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 thoughtfully

formulated

medicated lip balm

for fever blisters

and cold sores.

FOR EVERYONE AND THEIR MOTHER

Distributed by Earth Mama Angel Baby LLC

9866 SE Empire Ct., Clackamas, OR 97015 USA

EarthMama.com

Certified Organic by Oregon Tilth

B10-521-00

With Organic echinacea root, licorice root, chamomile and more.

Label Artwork

Carton Artwork


Advanced Ingredient Data


Raw Label Data

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