Qc Cold And Hot Pain Relief
FDA Label NDC 63868-012

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chain Drug Marketing Association Inc for the product Qc Cold And Hot Pain Relief (NDC 63868-012). 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 5.0%

Purpose

Topical Analgesic

Uses

temporarily relieves minor pain associated with

  • arthritis
  • simple backache
  • bursitis
  • tendonitis
  • muscle strains
  • sprains
  • bruises
  • cramps

Warnings

For external use only

When Using This Product

  • use only as directed
  • avoid contact with eyes and mucous membranes
  • do not bandage tightly or use with a heating pad
  • do not apply to wounds or damaged skin, broken or irritated skin

Stop Use And Ask A Doctor If

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

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:

  • carefully remove backing from patch
  • apply one patch to affected area
  • repeat as necessary, but no more than 4 times daily

    • Children 12 years or younger: ask a doctor

Inactive Ingredients

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

Package Label

QC Cold and Hot Patch

Image Of Carton Label (Qc.coldhot.carton)

Image Of Carton Label (Qc.coldhot.carton)

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