Icy Hot Performance Cream Pain Relief Cream
FDA Label NDC 41167-0803

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Icy Hot Performance Cream Pain Relief (NDC 41167-0803). 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 purpose, uses, warnings, do not use, 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

Purpose

Camphor 11% ……………………………………………………………………………………Topical analgesic

Menthol 16% ………………..……………………………………………………………………Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints associated with:  

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Warnings

For external use only

Do Not Use

  • on wounds or on irritated or damaged skin
  • with a heating pad

When Using This Product

  • use only as directed
  • do not bandage tightly
  • avoid contact with eyes and mucous membranes
  • do not expose the area to local heat or direct sunlight
  • rare cases of serious burns have been reported with products of this type
  • a transient burning sensation may occur upon application but generally disappears in several days
  • avoid applying into skin folds

Stop Use And Ask A Doctor If

  • condition worsens or symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days
  • redness is present or excessive skin irritation occurs
  • you experience severe burning pain, swelling, or blistering where the product was applied

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 12 years of age and older:
    • apply a thin layer to affected area not more than 3 to 4 times daily
    • massage until thoroughly absorbed into skin
    • if product unintentionally gets on hands, wash hands thoroughly with soap and water after each use

    • children under 12 years of age: ask a doctor

Inactive Ingredients

4-t-butylcyclohexanol, acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat., allantoin, aloe barbadensis leaf juice, cetyl alcohol, citrus paradisi (grapefruit) peel oil, farnesol, fragrance, glyceryl stearate, mentha piperita (peppermint) oil, mentha viridis (spearmint) leaf oil, pentylene glycol, propanediol, potassium hydroxide, steareth-21, stearic acid, water

     

Principal Display Panel

ICY HOT
PERFORMANCE
CREAM
PAIN RELIEF

Principal Display Panelicy Hotperformancecreampain Relief (Icy Hot Performance Cream 01)

Principal Display Panelicy Hotperformancecreampain Relief (Icy Hot Performance Cream 01)

     

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