SPL v1
SPL
SPL Set ID 3cd77075-0825-d283-e063-6294a90ae7b5
Route
TOPICAL
Published
Effective Date 2025-09-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Melissa Officinalis Leaf (28.35 g) Eucalyptus Oil (42.52 g) Melaleuca Alternifolia (tea Tree) Leaf Oil (1.2 g)
Inactive Ingredients
Coconut Oil Beeswax .alpha.-tocopherol Acetate, Dl- Flax Seed Argan Oil Grape Seed Oil Jojoba Oil Arctium Lappa Root Oregano

Identifiers & Packaging

Marketing Status
UNAPPROVED DRUG OTHER Active Since 2025-08-01

Description

Melissa officinalis (Lemon Balm) – Skin protectant Melaleuca alternifolia (Tea Tree) oil – Antimicrobial Eucalyptus globulus (Eucalyptus) oil – Soothing agent See uploaded back label image.

Purpose

Skin protectant / Antimicrobial / Soothing See uploaded back label image


Medication Information

Purpose

Skin protectant / Antimicrobial / Soothing See uploaded back label image

Description

Melissa officinalis (Lemon Balm) – Skin protectant Melaleuca alternifolia (Tea Tree) oil – Antimicrobial Eucalyptus globulus (Eucalyptus) oil – Soothing agent See uploaded back label image.

Purpose – Sea Jewels Lemon Balm Full Body Salve (4 Oz)

Skin protectant / Antimicrobial / Soothing

See uploaded back label image

Stop Use – Sea Jewels Lemon Balm Full Body Salve (4 Oz)

Stop use if condition worsens or rash develops

See uploaded back label image.

Warnings – Sea Jewels Lemon Balm Full Body Salve (4 Oz)

For external use only

See uploaded back label image.

Purpose – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz)

Skin protectant / Antimicrobial / Soothing

See uploaded back label image.

Do Not Use – Sea Jewels Lemon Balm Full Body Salve (4 Oz)

Do not use on deep puncture wounds or serious burns

See uploaded back label image.

Sea Jewels Lemon Balm Full Body Salve (4 Oz) – Side Label

Distributed by:

SEAJewels LLC

Stone Mountain, GA 30087

Email: [email protected]

See uploaded side panel label image.

Stop Use – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz)

Stop use if condition worsens or rash develops

See uploaded back label image.

Warnings – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz)

For external use only

See uploaded back label image.

When Using – Sea Jewels Lemon Balm Full Body Salve (4 Oz)

Avoid contact with eyes.

See uploaded back label image.

Sea Jewels Lemon Balm Full Body Salve (4 Oz) – Front Label

Sea Jewels Lemon Balm Full Body Salve

Net Wt. 113.4 g (4 oz)

See uploaded front label image.

Do Not Use – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz)

Do not use on deep puncture wounds or serious burns

See uploaded back label image.

Sea Jewels Lemon Balm Full Body Salve (0.5 Oz) – Back Label

Distributed by:

SEAJewels LLC

Stone Mountain, GA 30087

Email: [email protected]

See uploaded back label image.

When Using – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz)

Avoid contact with eyes

See uploaded back label image.

Sea Jewels Lemon Balm Full Body Salve (0.5 Oz) – Front Label

Sea Jewels Lemon Balm Full Body Salve

Net Wt. 14.17 g (0.5 oz)

See uploaded fron label images.

Active Ingredients – Sea Jewels Lemon Balm Full Body Salve (4 Oz)

Active ingredients

Melissa officinalis (Lemon Balm) – Skin protectant

Melaleuca alternifolia (Tea Tree) oil – Antimicrobial

Eucalyptus globulus (Eucalyptus) oil – Soothing agent

See uploaded back label image

Indications & Usage – Sea Jewels Lemon Balm Full Body Salve (4 Oz)

Helps comfort skin during periods of irritation or flare-ups

Helps relieve symptoms associated with:

• Cold sores and herpes outbreaks

• Eczema and rashes

• Ringworm and fungal irritation

• Minor boils and abscesses

• Insect bites

• Shingles flare-ups

• Minor burns

See uploaded back label image.

Active Ingredients – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz)

Melissa officinalis (Lemon Balm) – Skin protectant

Melaleuca alternifolia (Tea Tree) oil – Antimicrobial

Eucalyptus globulus (Eucalyptus) oil – Soothing agent

See uploaded back label image.

Inactive Ingredients – Sea Jewels Lemon Balm Full Body Salve (4 Oz)

Burdock Root, Oregano Leaf, Organic Flax Seeds, Jojoba Oil (100% Pure Cold-Pressed),

Vitamin E Oil, Organic Argan Oil, Grapeseed Oil (100% Pure Cold-Pressed),

Organic Coconut Oil, Organic Beeswax

See uploaded back label image.

Indications & Usage – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz)

- Helps comfort skin during periods of irritation or flare-ups

- Helps relieve symptoms associated with:

• Cold sores and herpes outbreaks

• Eczema and rashes

• Ringworm and fungal irritation

• Minor boils and abscesses

• Insect bites

• Shingles flare-ups

• Minor burns

See uploaded back label image.

Inactive Ingredients – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz)

Burdock Root, Oregano Leaf, Organic Flax Seeds, Jojoba Oil (100% Pure Cold-Pressed), Vitamin E Oil, Organic Argan Oil, Grapeseed Oil (100% Pure Cold-Pressed), Organic Coconut Oil, Organic Beeswax

See uploaded back label image.

Dosage & Administration – Sea Jewels Lemon Balm Full Body Salve (4 Oz)

Cleanse affected area before application

Apply a thin layer 2–3 times daily, or as needed

For open wounds, apply and cover with sterile gauze

See uploaded back label image.

Other Safety Information – Sea Jewels Lemon Balm Full Body Salve (4 Oz)

Store at room temperature, away from direct sunlight

See uploaded back label image.

Dosage & Administration – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz)

- Cleanse affected area before application

- Apply a thin layer 2–3 times daily, or as needed

- For open wounds, apply and cover with sterile gauze

See uploaded back label image.

Other Safety Information – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz)

Store at room temperature, away from direct sunlight

See uploaded back label image.

Keep Out of Reach of Children – Sea Jewels Lemon Balm Full Body Salve (4 Oz)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

See uploaded back label image.

Keep Out of Reach of Children – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

See uploaded back label image.


Structured Label Content

Purpose – Sea Jewels Lemon Balm Full Body Salve (4 Oz) (Purpose – Sea Jewels Lemon Balm Full Body Salve (4 oz))

Skin protectant / Antimicrobial / Soothing

See uploaded back label image

Stop Use – Sea Jewels Lemon Balm Full Body Salve (4 Oz) (Stop Use – Sea Jewels Lemon Balm Full Body Salve (4 oz))

Stop use if condition worsens or rash develops

See uploaded back label image.

Warnings – Sea Jewels Lemon Balm Full Body Salve (4 Oz) (Warnings – Sea Jewels Lemon Balm Full Body Salve (4 oz))

For external use only

See uploaded back label image.

Purpose – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz) (Purpose – Sea Jewels Lemon Balm Full Body Salve (0.5 oz))

Skin protectant / Antimicrobial / Soothing

See uploaded back label image.

Do Not Use – Sea Jewels Lemon Balm Full Body Salve (4 Oz) (Do Not Use – Sea Jewels Lemon Balm Full Body Salve (4 oz))

Do not use on deep puncture wounds or serious burns

See uploaded back label image.

Sea Jewels Lemon Balm Full Body Salve (4 Oz) – Side Label (Sea Jewels Lemon Balm Full Body Salve (4 oz) – Side Label)

Distributed by:

SEAJewels LLC

Stone Mountain, GA 30087

Email: [email protected]

See uploaded side panel label image.

Stop Use – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz) (Stop Use – Sea Jewels Lemon Balm Full Body Salve (0.5 oz))

Stop use if condition worsens or rash develops

See uploaded back label image.

Warnings – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz) (Warnings – Sea Jewels Lemon Balm Full Body Salve (0.5 oz))

For external use only

See uploaded back label image.

When Using – Sea Jewels Lemon Balm Full Body Salve (4 Oz) (When Using – Sea Jewels Lemon Balm Full Body Salve (4 oz))

Avoid contact with eyes.

See uploaded back label image.

Sea Jewels Lemon Balm Full Body Salve (4 Oz) – Front Label (Sea Jewels Lemon Balm Full Body Salve (4 oz) – Front Label)

Sea Jewels Lemon Balm Full Body Salve

Net Wt. 113.4 g (4 oz)

See uploaded front label image.

Do Not Use – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz) (Do Not Use – Sea Jewels Lemon Balm Full Body Salve (0.5 oz))

Do not use on deep puncture wounds or serious burns

See uploaded back label image.

Sea Jewels Lemon Balm Full Body Salve (0.5 Oz) – Back Label (Sea Jewels Lemon Balm Full Body Salve (0.5 oz) – Back Label)

Distributed by:

SEAJewels LLC

Stone Mountain, GA 30087

Email: [email protected]

See uploaded back label image.

When Using – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz) (When Using – Sea Jewels Lemon Balm Full Body Salve (0.5 oz))

Avoid contact with eyes

See uploaded back label image.

Sea Jewels Lemon Balm Full Body Salve (0.5 Oz) – Front Label (Sea Jewels Lemon Balm Full Body Salve (0.5 oz) – Front Label)

Sea Jewels Lemon Balm Full Body Salve

Net Wt. 14.17 g (0.5 oz)

See uploaded fron label images.

Active Ingredients – Sea Jewels Lemon Balm Full Body Salve (4 Oz) (Active Ingredients – Sea Jewels Lemon Balm Full Body Salve (4 oz))

Active ingredients

Melissa officinalis (Lemon Balm) – Skin protectant

Melaleuca alternifolia (Tea Tree) oil – Antimicrobial

Eucalyptus globulus (Eucalyptus) oil – Soothing agent

See uploaded back label image

Indications & Usage – Sea Jewels Lemon Balm Full Body Salve (4 Oz) (Indications & Usage – Sea Jewels Lemon Balm Full Body Salve (4 oz))

Helps comfort skin during periods of irritation or flare-ups

Helps relieve symptoms associated with:

• Cold sores and herpes outbreaks

• Eczema and rashes

• Ringworm and fungal irritation

• Minor boils and abscesses

• Insect bites

• Shingles flare-ups

• Minor burns

See uploaded back label image.

Active Ingredients – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz) (Active Ingredients – Sea Jewels Lemon Balm Full Body Salve (0.5 oz))

Melissa officinalis (Lemon Balm) – Skin protectant

Melaleuca alternifolia (Tea Tree) oil – Antimicrobial

Eucalyptus globulus (Eucalyptus) oil – Soothing agent

See uploaded back label image.

Inactive Ingredients – Sea Jewels Lemon Balm Full Body Salve (4 Oz) (Inactive Ingredients – Sea Jewels Lemon Balm Full Body Salve (4 oz))

Burdock Root, Oregano Leaf, Organic Flax Seeds, Jojoba Oil (100% Pure Cold-Pressed),

Vitamin E Oil, Organic Argan Oil, Grapeseed Oil (100% Pure Cold-Pressed),

Organic Coconut Oil, Organic Beeswax

See uploaded back label image.

Indications & Usage – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz) (Indications & Usage – Sea Jewels Lemon Balm Full Body Salve (0.5 oz))

- Helps comfort skin during periods of irritation or flare-ups

- Helps relieve symptoms associated with:

• Cold sores and herpes outbreaks

• Eczema and rashes

• Ringworm and fungal irritation

• Minor boils and abscesses

• Insect bites

• Shingles flare-ups

• Minor burns

See uploaded back label image.

Inactive Ingredients – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz) (Inactive Ingredients – Sea Jewels Lemon Balm Full Body Salve (0.5 oz))

Burdock Root, Oregano Leaf, Organic Flax Seeds, Jojoba Oil (100% Pure Cold-Pressed), Vitamin E Oil, Organic Argan Oil, Grapeseed Oil (100% Pure Cold-Pressed), Organic Coconut Oil, Organic Beeswax

See uploaded back label image.

Dosage & Administration – Sea Jewels Lemon Balm Full Body Salve (4 Oz) (Dosage & Administration – Sea Jewels Lemon Balm Full Body Salve (4 oz))

Cleanse affected area before application

Apply a thin layer 2–3 times daily, or as needed

For open wounds, apply and cover with sterile gauze

See uploaded back label image.

Other Safety Information – Sea Jewels Lemon Balm Full Body Salve (4 Oz) (Other Safety Information – Sea Jewels Lemon Balm Full Body Salve (4 oz))

Store at room temperature, away from direct sunlight

See uploaded back label image.

Dosage & Administration – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz) (Dosage & Administration – Sea Jewels Lemon Balm Full Body Salve (0.5 oz))

- Cleanse affected area before application

- Apply a thin layer 2–3 times daily, or as needed

- For open wounds, apply and cover with sterile gauze

See uploaded back label image.

Other Safety Information – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz) (Other Safety Information – Sea Jewels Lemon Balm Full Body Salve (0.5 oz))

Store at room temperature, away from direct sunlight

See uploaded back label image.

Keep Out of Reach of Children – Sea Jewels Lemon Balm Full Body Salve (4 Oz) (Keep Out of Reach of Children – Sea Jewels Lemon Balm Full Body Salve (4 oz))

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

See uploaded back label image.

Keep Out of Reach of Children – Sea Jewels Lemon Balm Full Body Salve (0.5 Oz) (Keep Out of Reach of Children – Sea Jewels Lemon Balm Full Body Salve (0.5 oz))

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

See uploaded back label image.


Advanced Ingredient Data


Raw Label Data

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