Icy Hot Pro Pain Massaging Balm Cream
FDA Label NDC 41167-0790

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 Pro Pain Massaging Balm (NDC 41167-0790). 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, do not use, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Camphor 11% 

Menthol 16%

Purpose

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.

This product is not a toy or intended for use by children.

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

Directions

  • adults and children 12 years of age and older:
    • massage into affected area using the no-mess balm not more than 3 to 4 times daily
    • wash hands thoroughly with soap and water if product comes in contact with hands

    • children under 12 years of age: ask a doctor

Inactive Ingredients

prunus amygdalus dulcis (sweet almond) oil, helianthus annuus (sunflower) seed wax, theobroma cacao (cocoa) seed butter, cocos nucifera (coconut) oil, persea gratissima (avocado) oil, hydrogenated vegetable oil, copernicia cerifera (carnauba) wax, synthetic beeswax, citrus paradisi (grapefruit) peel oil, eucalyptus globulus leaf oil, mentha piperita (peppermint) oil, mentha viridis (spearmint) leaf oil

Close cap tightly after use. Keep carton as it contains important information.

Keep carton as it contains important information. 

     

Principal Display Panel

ICY HOT Pro Pain Relief

Massaging Balm
NET WT 1.25 OZ (35 g)

A Blue Box With White Text And Blue Textdescription Automatically Generated (Icy Hot Pro Pain Relief Massaging Balm 01)

A Blue Box With White Text And Blue Textdescription Automatically Generated (Icy Hot Pro Pain Relief Massaging Balm 01)

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