Terrafreeze Pain Relief Cream
FDA Label NDC 71805-855

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Beyond Derma, Llc for the product Terrafreeze Pain Relief (NDC 71805-855). 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:, if pregnant or breastfeeding,, 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 10.00%

Methyl Salicylate 10.00%

Histamine DHCl 0.050%

Purpose

Topical Analgesic

Uses:

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

Warnings:

  • For External use only
  • Keep out of reach of children. If swallowed, consult physician.
  • Do not apply to wounds or damaged skin.

When Using This Product

  • Avoid contact with eyes.  If product gets into eyes, rinse thoroughly with water
  • Do not bandage tightly

Stop Use And Ask A Doctor If:

  • Rash appears
  • If symptoms persist for more than seven days, discontinue use and consult physician

If Pregnant Or Breastfeeding,

ask a healthcare professional before use.

Keep Out Of Reach Of Children.

If swallowed get medical help or contact Poison Control Center right away.

Directions

  • Adults and children two-years of age or older:  Apply to affected area 3-4 times daily.
  • Children under two-years of age:  Consult a physician

Other Information

  • Store at room temperature with lid closed tightly.

Other Ingredients

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Arnica Montana Extract, AScorbic Acid (Vitamin C), Bosewellia Serrata Extract, Bromelain, Butylene Glycol, C13-14 Isoparaffin, Chamomilla Recutta (Chamomile) Extract, Citric Acid, Curcuma Longa (Turmeric) Extract, Emu Oil, Ethylhexylglycerin, Ethylhexyl Stearate, Glycyrrhiza Glabra (licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Laureth-7, magnesium Sulfate, Methylsulfonylmethane (MSM), Niacin, Phenoxyethanol, Polyacrylamide, Polysorbate-80, Potassium Sorbate, Sodium Polyacrylate, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Tricedeth-6, Zingiber Officinale (Ginger) Root Extract

Questions Or Comments?

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