achy external analgesic

achy external analgesic
SPL v1
SPL
SPL Set ID 43b92d37-1561-003b-e054-00144ff88e88
Route
topical
Published
Effective Date 2016-12-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (28 g)
Inactive Ingredients
olive oil arnica montana flower comfrey leaf west indian lemongrass oil rosemary oil white wax clary sage oil .alpha.-tocopherol

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2016-12-19
Description

Menthol 1.5%

Medication Information

Warnings and Precautions

Warnings

For external use only.

Do not use other than directed

When using this product

  • avoid contact with eyes and mucous membranes
  • do not apply tp wounds or broken skin

Stop use and ask a doctor if

  • excessive skin irritation develops
  • condition worsens
Active Ingredient

Menthol 1.5%

Indications and Usage

Temporarily relieves the minor aches and pains associated with tendonitis, backache, leg cramps, sore muscles, arthritis, bruises, sprains, and swelling.​

Dosage and Administration

Adults and children 3 years of age and older liberally massage to affected are not more than 4 times daily

Children under 3 years of age ask a doctor before using

Description

Menthol 1.5%

Section 50565-1

Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away (1-800-222-1222

Section 51727-6

Organic extra virgin olive oil, organic comfrey oil, organic arnica oil, beeswax, Indian lemongrass essenttial oil, French clary sage essential oil, Spanish rosemary essential oil, and Natural Vitamin E

Section 51945-4

Section 55105-1

Temporarily relieves the minor aches and pains associated with tendonitis, backache, leg cramps, sore muscles, arthritis, bruises, sprains, and swelling.

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only.

Do not use other than directed

When using this product

  • avoid contact with eyes and mucous membranes
  • do not apply tp wounds or broken skin

Stop use and ask a doctor if

  • excessive skin irritation develops
  • condition worsens
Active Ingredient (55106-9)

Menthol 1.5%

Indications and Usage (34067-9)

Temporarily relieves the minor aches and pains associated with tendonitis, backache, leg cramps, sore muscles, arthritis, bruises, sprains, and swelling.​

Dosage and Administration (34068-7)

Adults and children 3 years of age and older liberally massage to affected are not more than 4 times daily

Children under 3 years of age ask a doctor before using

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed get medical help or contact Poison Control Center right away (1-800-222-1222

Section 51727-6 (51727-6)

Organic extra virgin olive oil, organic comfrey oil, organic arnica oil, beeswax, Indian lemongrass essenttial oil, French clary sage essential oil, Spanish rosemary essential oil, and Natural Vitamin E

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Temporarily relieves the minor aches and pains associated with tendonitis, backache, leg cramps, sore muscles, arthritis, bruises, sprains, and swelling.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:16.002250 · Updated: 2026-03-14T22:54:36.982637