flexdermal pain relieving roll-on ointment

flexdermal pain relieving roll-on ointment
SPL v1
SPL
SPL Set ID d4d8050e-0761-4491-8635-39c806701eb5
Route
topical
Published
Effective Date 2025-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
menthol (20 mg)
Inactive Ingredients
fd&c blue no. 1 ethylhexylglycerin glycerin isopropyl alcohol phenoxyethanol sodium hydroxide water

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-01-24
Purpose

Topical Analgesic

Description

Menthol 2.00%

Medication Information

Warnings

For external use only

Uses
  • For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, strains, bruises, and sprains.
Purpose

Topical Analgesic

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: consult a doctor.
Other Information
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Blue 1 (CI 42090), Camphor, Ethylhexylglycerin, Glycerin, Isopropyl Alcohol, Phenoxyethanol, Sodium Hydroxide, Water(Aqua)

Description

Menthol 2.00%

Questions?

888-211-8468

Do Not 
  • apply to wounds or damaged skin.
  • bandage tightly.
Drug Facts

Package Labeling:

Active Ingredients

Menthol 2.00%

When Using This Product
  • Avoid contact with the eyes.
Stop Use and Ask A Doctor If
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
If Pregnant Or Breast Feeding,

ask a health professional before use

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Structured Label Content

Warnings

For external use only

Uses
  • For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, strains, bruises, and sprains.
Purpose

Topical Analgesic

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: consult a doctor.
Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Blue 1 (CI 42090), Camphor, Ethylhexylglycerin, Glycerin, Isopropyl Alcohol, Phenoxyethanol, Sodium Hydroxide, Water(Aqua)

Questions?

888-211-8468

Do Not  (Do not )
  • apply to wounds or damaged skin.
  • bandage tightly.
Drug Facts

Package Labeling:

Active Ingredients (Active ingredients)

Menthol 2.00%

When Using This Product (When using this product)
  • Avoid contact with the eyes.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:30.280661 · Updated: 2026-03-14T23:07:24.321893