48739205-627b-41d0-e063-6394a90a3462

SPL v1
SPL
SPL Set ID 48739205-627b-41d0-e063-6394a90a3462
Route
topical
Published
Effective Date 2026-01-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (4 g)

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2026-01-15

Purpose

Extenal Analgesic

Description

Mentho1 4%


Medication Information

Warnings

For external use only.

Do not use on:

• Broken skin

• Wounds

• Irritated skin

When using this product:

• Avoid contact with eyes and mucous membranes

• Do not bandage tightly

• Do not apply heat to the treated area

Stop use and ask a doctor if:

• Condition worsens

• Symptoms persist for more than 7 days

• Redness or irritation develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Temporarily relieves minor aches and pains of muscles and joints.

Purpose

Extenal Analgesic

Directions

adults and children 12 years of age and older:

apply to affected area no more than 3 to 4 times daily

children under 12 years of age:

ask a doctor

Description

Mentho1 4%

Principal Display Panel

Neuropathy Cream

Menthol 1%

Topical Analgesic

Net Wt. XX oz (XX g)

For external use only

Distributed by:

Owell Naturals Brand, LLC

USA

Questions?

Questions or comments?

Call 1-800-XXX-XXXX

Manufactured for: Your Company Name

City, State, ZIP

Do Not Use

On wound or Damage skin

Active Ingredient

Mentho1 4%

When Using This Product

do not get into eyes or mucous membranes

do not bandage tightly

Principlal Display Panel

see product image

Stop Use and Ask A Doctor If

condition worsens

symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients: Purified Water, Glycerin

none


Structured Label Content

Warnings (WARNINGS)

For external use only.

Do not use on:

• Broken skin

• Wounds

• Irritated skin

When using this product:

• Avoid contact with eyes and mucous membranes

• Do not bandage tightly

• Do not apply heat to the treated area

Stop use and ask a doctor if:

• Condition worsens

• Symptoms persist for more than 7 days

• Redness or irritation develops

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Temporarily relieves minor aches and pains of muscles and joints.

Purpose

Extenal Analgesic

Directions

adults and children 12 years of age and older:

apply to affected area no more than 3 to 4 times daily

children under 12 years of age:

ask a doctor

Principal Display Panel

Neuropathy Cream

Menthol 1%

Topical Analgesic

Net Wt. XX oz (XX g)

For external use only

Distributed by:

Owell Naturals Brand, LLC

USA

Questions?

Questions or comments?

Call 1-800-XXX-XXXX

Manufactured for: Your Company Name

City, State, ZIP

Do Not Use (Do not use)

On wound or Damage skin

Active Ingredient (Active ingredient)

Mentho1 4%

When Using This Product (When using this product)

do not get into eyes or mucous membranes

do not bandage tightly

Principlal Display Panel (principlal display panel)

see product image

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens

symptoms persist for more than 7 days or clear up and occur again within a few days

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients: Purified Water, Glycerin (Inactive ingredients: purified water, glycerin)

none


Advanced Ingredient Data


Raw Label Data

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