SPL v1
SPL
SPL Set ID 3fbbe613-6a5b-5fd1-e063-6394a90a7422
Route
TOPICAL
Published
Effective Date 2025-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (6.5 g) Camphor (natural)
Inactive Ingredients
Cocoa Butter Butyrospermum Parkii (shea) Butter Mangifera Indica Seed Butter Helichrysum Gymnocephalum Whole Cinnamon Leaf Oil Ginger Oil Avocado Oil Black Pepper Oil Clove Oil Beeswax Frankincense .alpha.-tocopherol Acetate, D- Persea Gratissima (avocado) Seed

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-09-29
Description

Menthol 4.3%................External analgesic Camphor 4.3%..............External analgesic

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 older. Apply to affected area not more than 3-4 times per day

Description

Menthol 4.3%................External analgesic Camphor 4.3%..............External analgesic

Section 50565-1

If swallowed, seek immediate medical attention or contact Poison Control

Section 50566-9

Stop use and ask a medical doctor if condition worsens, or symptoms persist

Section 50570-1

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

Section 51727-6

Inactive ingredients: Aaloe vera juice, Witch hazel, Avocado oil, Menthol crystals, Camphor, Ginger essential oil, Frankincense essential oil, Helichrysum essential oil, Optiphen, and Vitamin E

Section 51945-4

Section 55105-1

Topical analgesic for temporary relief of pain/itching due to sunburn, minor burns, insect bites, and everyday aches

Section 55106-9

Menthol 4.3%................External analgesic

Camphor 4.3%..............External analgesic

Structured Label Content

Indications and Usage (34067-9)

Route of administration: Topical

Dosage and Administration (34068-7)

Directions: Adults and children 12+ years and older. Apply to affected area not more than 3-4 times per day

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 medical doctor if condition worsens, or symptoms persist

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients: Aaloe vera juice, Witch hazel, Avocado oil, Menthol crystals, Camphor, Ginger essential oil, Frankincense essential oil, Helichrysum essential oil, Optiphen, and Vitamin E

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical analgesic for temporary relief of pain/itching due to sunburn, minor burns, insect bites, and everyday aches

Section 55106-9 (55106-9)

Menthol 4.3%................External analgesic

Camphor 4.3%..............External analgesic

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:08.575813 · Updated: 2026-03-14T23:10:21.394156