Kineticream Pain Relieving Topical Analgesic Cream
FDA Label NDC 58611-971

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Phoenix Bioperformance Products Llc for the product Kineticream Pain Relieving Topical Analgesic (NDC 58611-971). 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:, keep out of reach of children., if pregnant or breast feeding,, directions., 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 2.00%

Purpose

External Analgesic

Uses:

For temporary relief of minor aches and pains associated with backache, muscle ache, joint pain, arthritis, bruises and sprains.

Warnings:

  • For external use only.
  • Avoid contact with eyes.
  • Do not apply to open wounds or damaged skin.
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep Out Of Reach Of Children.

  • If swallowed, consult physician.
  • Do not bandage tightly.

If Pregnant Or Breast Feeding,

consult physician prior to use.

Directions.

Shake well prior to using. Apply to area of discomfort. Smooth out and allow to absorb into skin. Do not use more than four times per day.Do not use near eyes. For best results, use immediately after showering.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Juice) Gel, Aqua (Deionized Water), Arnica Montrana Flower Extract, Bromelain, Butyrospermum Parkii (Shea) Butter, C13-14 lsoparaffin, Calophyllum Tacamahaca (Tamanu) Oil, Camellia Sinensis Leaf (Green Tea) Extract, Cetearyl Alcohol, Cetyl Myristoleate, Chondroitin Sulfate, Citric Acid, Citrus Aurantium Bergamia (Bergamot) Oil, Dimethyl Sulfone (MSM), Emu Oil, Ethylhexylglycerin, Glycerin, Glucosamine Sulfate, Glyceryl Stearate SE, Laureth-7, Melia Azadirachta (Neem) Seed Oil, Mentha Piperita (Peppermint) Oil, Papain, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Salix Alba (Willow Bark) Extract, SD-Alcohol 40B, Sesamum lndicum (Sesame) Oil, Stearic Acid, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate (Vitamin-E), Xanthan Gum.

Questions Or Comments?

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