SPL v1
SPL
SPL Set ID 3c6b0114-0bc9-a150-e063-6394a90a191d
Route
TOPICAL
Published
Effective Date 2025-09-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (4.8 g) Camphor (natural)
Inactive Ingredients
Beeswax Ginger Oil Cocoa Butter Avocado Oil Shea Butter Mangifera Indica (mango) Seed Butter Avocado Seed Helichrysum Gymnocephalum Whole Frankincense .alpha.-tocopherol Acetate, D-

Identifiers & Packaging

Pill Appearance
Color: brown
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-08
Description

Topical analgesic for temporary relief of minor aches and pain of muscles and joints associated with backach, arthritis, strains, brusies, and sprains

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Route of Administration:Topical

Dosage and Administration

Directions:

Adults and children 12 years and over: Apply to the affected area not more than 3 to 4 times daily.

Route of Administration:Topical (external) use only

Description

Topical analgesic for temporary relief of minor aches and pain of muscles and joints associated with backach, arthritis, strains, brusies, and sprains

Section 50565-1

If swallowed, seek immediate medical attention or contact Poison Control

Section 50566-9

Stop use and ask a doctor if: condition worsens, or symptoms persist for more than 7 days.

Section 50570-1

Do not use on open wounds, broken skin, or with a heating pad

Section 51727-6

Inactive ingredients: beeswax, avocado oil, shea butter, cocoa butter, mango butter, menthol crystals, avocado seed powder, camphor, helichrysum, frankincense, ginger oil, vitamin e

Section 51945-4

Section 55105-1

Topical analgesic for temporary relief of minor aches and pain of muscles and joints associated with backach, arthritis, strains, brusies, and sprains

Structured Label Content

Indications and Usage (34067-9)

Route of Administration:Topical

Dosage and Administration (34068-7)

Directions:

Adults and children 12 years and over: Apply to the affected area not more than 3 to 4 times daily.

Route of Administration:Topical (external) use only

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

If swallowed, seek immediate medical attention or contact Poison Control

Section 50566-9 (50566-9)

Stop use and ask a doctor if: condition worsens, or symptoms persist for more than 7 days.

Section 50570-1 (50570-1)

Do not use on open wounds, broken skin, or with a heating pad

Section 51727-6 (51727-6)

Inactive ingredients: beeswax, avocado oil, shea butter, cocoa butter, mango butter, menthol crystals, avocado seed powder, camphor, helichrysum, frankincense, ginger oil, vitamin e

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical analgesic for temporary relief of minor aches and pain of muscles and joints associated with backach, arthritis, strains, brusies, and sprains

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:56.485852 · Updated: 2026-03-14T23:10:01.237919