Dirt Pain Relieving Gel
FDA Label NDC 83067-363

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Purivitae, Llc for the product Dirt Pain Relieving Gel (NDC 83067-363). 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 ingredients:, purpose, uses:, warnings:, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients:

Menthol 4%

Purpose

Topical Analgesic

Uses:

For the temporary relief of minor aches and pains of muscles and joints, associated with arthritis, simple back aches, strains, bruises, and sprains.

Warnings:

For external use only

Do Not Use

  • on damaged or brokin skin.

When Using This Product

  • Avoid contact with the eyes.
  • Do not bandage tightly.

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.

Keep Out Of Reach Of Children.

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

If Pregnant Or Breast-Feeding,

ask a health professional before use

Directions:

Adults and children over 12 years of age: 

  • apply generously to affected areas
  • rub into affected area until absorbed into the skin
  • repeat as necessary, but no more than 4 times daily

    • Children 12 years or younger: ask a doctor

Inactive Ingredients:

Activated Charcoal, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Boswellia Serrata Extract, Calendula Officinalis Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Ilex Paraguariensis (Yerba Mate') Extract, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmethane (MSM), Phenoxyethanol, Polysorbate-20, Propylene Glycol, SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E), Triethanolamine.

Package Labeling:

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