Amish Origins Pain Relieving Menthol 8% Ointment
FDA Label NDC 62212-002

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Amish Origins Management, Llc for the product Amish Origins Pain Relieving Menthol 8% (NDC 62212-002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Menthol 8%

Purpose

External Analgesic

Uses

For the temporary relief of minor aches and pain of muscles and joints associated with arthritis

Warnings

For external use only.

When Using This Product

  • avoid contact with the eyes
  • do not apply to wounds or damaged skin
  • do not bandage tightly

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children.

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

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: do not use, consult a doctor.

Other Information

  • Store at room temperature

Inactive Ingredients

Camphor Oil, Eucalyptus Oil, Methyl Salicylate, Pine Needle Oil, Snow White Petrolatum

Questions Or Comments?

1-888-530-7643

Package Labeling:

Label03 (Label03)

Label03 (Label03)

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