SPL v3
SPL
SPL Set ID 25b9621b-3c16-3cb9-e063-6294a90ab598
Route
TOPICAL
Published
Effective Date 2024-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.025 g) Levomenthol (4 g)
Inactive Ingredients
Caprylic/capric Triglyceride Edetate Disodium Kawakawa Jojoba Oil Glyceryl Stearate Helianthus Annuus Seed Wax Ceteareth-20 Lecithin, Soybean Coconut Oil Cetearyl Alcohol Iodopropynyl Butylcarbamate Sodium Stearoyl Glutamate Xanthan Gum Dimethicone Glycerin Cetyl Alcohol Water Stearyl Alcohol Isopropyl Myristate Turmeric Oil Aloe Vera Leaf Magnesium Aluminum Silicate Polyglycerin-3 Alcohol Safflower Oil Ascorbyl Palmitate Diazolidinyl Urea

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-30
Description

Active Ingredients Purpose Menthol 4% .................................................Topical Analgesic Capsaicin 0.025% .........................................Topical Analgesic

Indications and Usage

Formatting of the following sections were changed: Indications and Usage Dosage and Administration Contents remain the same as before. March 2025

Medication Information

Warnings and Precautions

Warnings

For external use only.

When using this product

• Avoid contact with eyes • Do not apply to

open wounds or damaged skin

• Avoid using under tight bandages.

Stop use and consult a physician if

symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a

healthcare professional before use.

Keep out of reach of children.

If swallowed, get medical help immediately.

Indications and Usage

Uses

For the temporary relief of minor aches and

pains of muscles and joints associated

with:

• Arthritis • Simple backache • Sprains

• Bruises • Strains

Dosage and Administration

Directions

Adults and children 2 years of age and

older • Apply to affected area not more

than 3 to 4 times daily.

Children under 2 years of age • Do not

use, consult a physician.

Description

Active Ingredients Purpose Menthol 4% .................................................Topical Analgesic Capsaicin 0.025% .........................................Topical Analgesic

Section 44425-7

Other Information

Store at room temperature.

Section 50565-1

Warnings

For external use only.

When using this product

• Avoid contact with eyes • Do not apply to

open wounds or damaged skin

• Avoid using under tight bandages.

Stop use and consult a physician if

symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a

healthcare professional before use.

Keep out of reach of children.

If swallowed, get medical help immediately.

Section 50566-9

Warnings

For external use only.

When using this product

• Avoid contact with eyes • Do not apply to

open wounds or damaged skin

• Avoid using under tight bandages.

Stop use and consult a physician if

symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a

healthcare professional before use.

Keep out of reach of children.

If swallowed, get medical help immediately.

Section 50567-7

Warnings

For external use only.

When using this product

• Avoid contact with eyes • Do not apply to

open wounds or damaged skin

• Avoid using under tight bandages.

Stop use and consult a physician if

symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a

healthcare professional before use.

Keep out of reach of children.

If swallowed, get medical help immediately.

Section 50570-1

Warnings

For external use only.

When using this product

• Avoid contact with eyes • Do not apply to

open wounds or damaged skin

• Avoid using under tight bandages.

Stop use and consult a physician if

symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a

healthcare professional before use.

Keep out of reach of children.

If swallowed, get medical help immediately.

Section 51727-6

Inactive Ingredients

Alcohol, Aloe Vera Leaf Extract, Ascorbyl

Palmitate, Caprylic/Capric Triglyceride,

Ceteareth-20, Cetearyl Alcohol, Cetyl

Alcohol, Coconut Oil, Diazolidinyl Urea,

Dimethicone, Edetate Disodium, Glycerin,

Glyceryl Stearate, Helianthus Annuus Seed

Wax, Iodopropynyl Butylcarbamate,

Isopropyl Myristate, Jojoba Esters,

Kawakawa Extract, Lecithin, Magnesium

Aluminum Silicate, Polyglycerin-3,

Safflower Oil, Sodium Stearoyl Glutamate,

Stearyl Alcohol, Turmeric Oil, Water,

Xanthan Gum.

Section 51945-4

Section 53414-9

Warnings

For external use only.

When using this product

• Avoid contact with eyes • Do not apply to

open wounds or damaged skin

• Avoid using under tight bandages.

Stop use and consult a physician if

symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a

healthcare professional before use.

Keep out of reach of children.

If swallowed, get medical help immediately.

Section 55105-1

Uses

For the temporary relief of minor aches and

pains of muscles and joints associated

with:

• Arthritis • Simple backache • Sprains

• Bruises • Strains

Section 55106-9

Active Ingredients Purpose

Menthol 4% .................................................Topical Analgesic

Capsaicin 0.025% .........................................Topical Analgesic

Change to Indications and Usage, Directions Sections

Formatting of the following sections were changed:

  • Indications and Usage
  • Dosage and Administration

Contents remain the same as before.

March 2025

Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of minor aches and

pains of muscles and joints associated

with:

• Arthritis • Simple backache • Sprains

• Bruises • Strains

Dosage and Administration (34068-7)

Directions

Adults and children 2 years of age and

older • Apply to affected area not more

than 3 to 4 times daily.

Children under 2 years of age • Do not

use, consult a physician.

Warnings and Precautions (34071-1)

Warnings

For external use only.

When using this product

• Avoid contact with eyes • Do not apply to

open wounds or damaged skin

• Avoid using under tight bandages.

Stop use and consult a physician if

symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a

healthcare professional before use.

Keep out of reach of children.

If swallowed, get medical help immediately.

Section 44425-7 (44425-7)

Other Information

Store at room temperature.

Section 50565-1 (50565-1)

Warnings

For external use only.

When using this product

• Avoid contact with eyes • Do not apply to

open wounds or damaged skin

• Avoid using under tight bandages.

Stop use and consult a physician if

symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a

healthcare professional before use.

Keep out of reach of children.

If swallowed, get medical help immediately.

Section 50566-9 (50566-9)

Warnings

For external use only.

When using this product

• Avoid contact with eyes • Do not apply to

open wounds or damaged skin

• Avoid using under tight bandages.

Stop use and consult a physician if

symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a

healthcare professional before use.

Keep out of reach of children.

If swallowed, get medical help immediately.

Section 50567-7 (50567-7)

Warnings

For external use only.

When using this product

• Avoid contact with eyes • Do not apply to

open wounds or damaged skin

• Avoid using under tight bandages.

Stop use and consult a physician if

symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a

healthcare professional before use.

Keep out of reach of children.

If swallowed, get medical help immediately.

Section 50570-1 (50570-1)

Warnings

For external use only.

When using this product

• Avoid contact with eyes • Do not apply to

open wounds or damaged skin

• Avoid using under tight bandages.

Stop use and consult a physician if

symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a

healthcare professional before use.

Keep out of reach of children.

If swallowed, get medical help immediately.

Section 51727-6 (51727-6)

Inactive Ingredients

Alcohol, Aloe Vera Leaf Extract, Ascorbyl

Palmitate, Caprylic/Capric Triglyceride,

Ceteareth-20, Cetearyl Alcohol, Cetyl

Alcohol, Coconut Oil, Diazolidinyl Urea,

Dimethicone, Edetate Disodium, Glycerin,

Glyceryl Stearate, Helianthus Annuus Seed

Wax, Iodopropynyl Butylcarbamate,

Isopropyl Myristate, Jojoba Esters,

Kawakawa Extract, Lecithin, Magnesium

Aluminum Silicate, Polyglycerin-3,

Safflower Oil, Sodium Stearoyl Glutamate,

Stearyl Alcohol, Turmeric Oil, Water,

Xanthan Gum.

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

Warnings

For external use only.

When using this product

• Avoid contact with eyes • Do not apply to

open wounds or damaged skin

• Avoid using under tight bandages.

Stop use and consult a physician if

symptoms persist for more than 7 days.

If pregnant or breast-feeding, ask a

healthcare professional before use.

Keep out of reach of children.

If swallowed, get medical help immediately.

Section 55105-1 (55105-1)

Uses

For the temporary relief of minor aches and

pains of muscles and joints associated

with:

• Arthritis • Simple backache • Sprains

• Bruises • Strains

Section 55106-9 (55106-9)

Active Ingredients Purpose

Menthol 4% .................................................Topical Analgesic

Capsaicin 0.025% .........................................Topical Analgesic

Change to Indications and Usage, Directions Sections (Change to Indications and Usage, Directions sections)

Formatting of the following sections were changed:

  • Indications and Usage
  • Dosage and Administration

Contents remain the same as before.

March 2025

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:40.847126 · Updated: 2026-03-14T23:07:51.764628