Cold And Hot Pain Relief
FDA Label NDC 59970-080

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Navarro Discount Pharmacies,llc for the product Cold And Hot Pain Relief (NDC 59970-080). 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, if pregnant or breast-feeding,, 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

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Uses

Temporarily relieves minor pain associated with:
  • arthritis
  • muscle strains
  • simple backache
  • bursitis
  • cramps
  • tendonitis
  • muscle sprains
  • bruises

Warnings

For external use only

When Using This Product

  • use only as directed
  • do not bandage tightly
  • do not use a heating pad
  • avoid contact with eyes and mucous membrane
  • do not apply to wounds or damaged skin
  • do not use if you are allergic to any ingredients of this product

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness is present
  • irritation develops

If Pregnant Or Breast-Feeding,

Ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

Adults and children over 12 years:

  • Remove backing from patch by grasping both ends firmly
  • Carefully remove backing from patch
  • Apply one patch to affected area
  • Repeat as necessary, but no more than 4 times daily

    • Children under 12 years of age: Ask a doctor

Other Information

Store at room temperature

Inactive Ingredients

aluminium glycinate, 1,3-butylene Glycol, carboxymethylcellulose Sodium, concentrated Glycerin, diethylene glycolmonoethyl Ether, disodium edetate, methyl parahydroxybenzoate, polyacrylic acid solution, polysorbate 80, propyl parahydroxybenzoate, purified water, sodium polyacrylate, tartaric acid, titanium dioxide

Package Label


Cold and Hot Pain Relief Patch

Image Of Carton Label (Nav.largepatch.carton)

Image Of Carton Label (Nav.largepatch.carton)

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