Dr. Mikes Ponos Pain Relief Cream Roll-on Cream
FDA Label NDC 71067-359

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dr. Mike's Vitamins, Llc for the product Dr. Mikes Ponos Pain Relief Cream Roll-on (NDC 71067-359). 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:, 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 Ingredients

Histamine DHCl 0.03 %

Menthol 3%

Purpose

Topical Analgesic

Uses:

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

Warnings:

For external use only

Do not • apply to wounds or damaged skin. • bandage tightly.

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.

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:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Flower Extract, Beeswax, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Cetearyl Olivate, Cetyl Alcohol, Cetyl Myristoleate, Chamomilla Matricaria (Chamomile) Extract, Citric Acid, Cucumis Sativus (Cucumber) Fruit Extract, Dimethyl Sulfone (DMSO), Gluconolactone, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Helianthus Annuus (Sunflower) Oil, Hypericum Perforatum (St. John's Wort), Mentha Piperita (Peppermint) Oil, Methylsulfonylmethane (MSM), Olea Europaea (Olive) Oil, Pistacia Lentiscus (Mastic) Oil, Sodium Benzoate, Sodium Laurylglucosides Hydroxypropyl sulfonate, Sorbitan Olivate, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol, Zingiber Officinalis (Ginger) Oil.

Questions Or Comments?

Go to www.drmikesvitamins.com

Package Labeling:

Bottle (Bottle)

Bottle (Bottle)

* Please review the disclaimer below.