Hav Ez Penetrating Pain Relief Gel
FDA Label NDC 84093-442

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Palm Orthopedics & Interventional Pain Llc for the product Hav Ez Penetrating Pain Relief (NDC 84093-442). 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:, warning:, 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 3.00 %

Purpose

Topical Analgesic

Uses:

Temporary relief of minor aches and pains of muscles and joints, associated with • arthritis simple backache • strains • bruises • sprains.

Warning:

For external use only

Do Not Use:

On damaged or broken skin

When Using This Product

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

Stop Use And Ask A Doctor If

  • Rash or irritation develops and lasts
  • 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 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, Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Deionized Water), Amica Montana Flower Extract, Boswellia Carterii (Frankincense) Oil, Cannabis Saliva (Hemp) Seed Oil, Caprylic/Capric Triglyceride, Cinnamomum Cassia Leaf Oil, Curcuma Longa (Turmeric) Extract, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Ilex Paraguariensis (Yerba Mate') Extract, Magnesium Sulfate, Olea Europaea (Olive) Oil, Phenoxyethanol, Piper Nigrum (Black Pepper) Extract, Polysorbate-20, Propylene Glycol, Triethanolamine

Package Labeling:

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