SPL v1
SPL
SPL Set ID 3c6c16bb-1f4b-b851-e063-6294a90a7404
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01
Description

Active Ingredients Menthol 1%

Medication Information

Warnings and Precautions

For external use only When using this productavoid 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 swalowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Indications and Usage

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

Dosage and Administration

adults & children 2 years of age and older: apply a smal 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 42229-5

Carton Text Herbal Fever Blister & Cold Sore Treatmentearth 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 thoughtfuly formulated medicated lip balm for fever blisters and cold sores. FOR EVERYONE AND THEIR MOTHER Distributed by Eleeo Brands LLC 2150 Winchell Ave. Cincinnati, OH 45214 USA EarthMama.com Certified Organic by Oregon Tilth B10-521-00 With Organic echinacea root, licorice root, chamomile and more.

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 FREEDistributed by Eleeo Brands 2150 Winchell Ave. Cincinnati, OH 45214 USA EarthMama.com Certified Organic by Oregon Tilth L10-521-00 Refreshing Menthol Mint

Section 44425-7

Other informationprotect 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 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 51945-4

Section 53413-1

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

Section 55105-1

Fever blister / cold sore treatment

Section 55106-9

Active Ingredients Menthol 1%

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

adults & children 2 years of age and older: apply a smal 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)

For external use only When using this productavoid 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 swalowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Section 42229-5 (42229-5)

Carton Text Herbal Fever Blister & Cold Sore Treatmentearth 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 thoughtfuly formulated medicated lip balm for fever blisters and cold sores. FOR EVERYONE AND THEIR MOTHER Distributed by Eleeo Brands LLC 2150 Winchell Ave. Cincinnati, OH 45214 USA EarthMama.com Certified Organic by Oregon Tilth B10-521-00 With Organic echinacea root, licorice root, chamomile and more.

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 FREEDistributed by Eleeo Brands 2150 Winchell Ave. Cincinnati, OH 45214 USA EarthMama.com Certified Organic by Oregon Tilth L10-521-00 Refreshing Menthol Mint

Section 44425-7 (44425-7)

Other informationprotect 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 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 51945-4 (51945-4)

Section 53413-1 (53413-1)

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

Section 55105-1 (55105-1)

Fever blister / cold sore treatment

Section 55106-9 (55106-9)

Active Ingredients Menthol 1%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:47.030032 · Updated: 2026-03-14T23:09:44.239716