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
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.

Section 55106-9

Menthol 1.5%

Structured Label Content

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

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
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.

Section 55106-9 (55106-9)

Menthol 1.5%

Advanced Ingredient Data

Raw Label Data

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Additional Information

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