Icy Hot Pro No-mess Cream
FDA Label NDC 41167-0079

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 No-mess (NDC 41167-0079). 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, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Purpose

Camphor 11%, 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

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 to affected area not more than 3 to 4 times daily
    ■ remove protective cap and lift white applicator at arrows
    ■ squeeze tube gently while holding upright to dispense a small amount of product
    ■ press down to close applicator prior to application
    ■ massage product into skin using applicator until thoroughly absorbed
    ■ if needed, clean applicator by rinsing with water or wipe clean with a cloth.
    ■ 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

water, propanediol, steareth-21, alcohol denat. (5%), glyceryl stearate, cetyl alcohol, farnesol, stearic acid, aloe barbadensis leaf juice, acrylates/C10-30 alkyl acrylate crosspolymer, menthyl lactate, diisopropyl adipate, pentylene glycol, 4-t-butylcyclohexanol, triethanolamine, allantoin, fragrance, citrus paradisi (grapefruit) peel oil, mentha piperita (peppermint) oil, mentha viridis (spearmint) leaf oil, ethoxydiglycol, glyceryl dilaurate, polysorbate 80, PEG-150 stearate, glycine soja (soybean) sterols, phenoxyethanol, methylparaben, glycerin, disodium EDTA, xanthan gum

333-169

Close cap tightly after use.

Principal Display Panel

ICY HOT
PRO
NO MESS
Pain reliever
NET WT 3 OZ (85 g)

Principal Display Panelicyhotprono Messpain Relievernet Wt 3 Oz (85 G) (Icy Hot Pro No Mess Pain Reliever 01)

Principal Display Panelicyhotprono Messpain Relievernet Wt 3 Oz (85 G) (Icy Hot Pro No Mess Pain Reliever 01)

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