Qc Cold And Hot Pain Relief
FDA Label NDC 64525-5131

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Quality Home Products for the product Qc Cold And Hot Pain Relief (NDC 64525-5131). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 5.0%

Purpose

Topical Analgesic Patch

Uses

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

Warnings

For external use only

When Using This Product

  • avoid contact with eyes
  • do not apply to wounds or damaged skin
  • 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.

Directions

  • Adults and children 10 years of age and older: Apply to affected area not more than 3 to 4 times daily
    • Children under 10 years of age: do not use, consult a doctor

Inactive Ingredients

Purified Water, Acrylic Acid, Aluminum Hydroxide, Carmellose sodium, 2-Ethylhexyl Acrylate, Glycerin, Isopropyl Myristate, Methyl Acrylate, Nonoxymol-30, Sodium Polyacrylate, Polyacrylic Acid, Polysorbate 80, Sorbitan Sesquioleate, Starch, Talc, Tartaric acid, Titanium Dioxide

Package Label

QC Cold and Hot Patch

* Please review the disclaimer below.