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

Description

Menthol 2.00%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 2.00%

Uses
  • For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, strains, bruises, and sprains.
Do Not 
  • apply to wounds or damaged skin.
  • bandage tightly.
Warnings

For external use only

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.
Drug Facts

Questions?

888-211-8468

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

Active Ingredients

Menthol 2.00%

Inactive Ingredients

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

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

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

Topical Analgesic

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

For external use only

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.
Drug Facts

Questions?

888-211-8468

Other Information (Other information)
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

Active Ingredients (Active ingredients)

Menthol 2.00%

Inactive Ingredients

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

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

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