FDA Label for Icy Hot Pro Pain Relief Cream W/ Microbeads

View Indications, Usage & Precautions

Icy Hot Pro Pain Relief Cream W/ Microbeads Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 a thin layer to affected area not more than 3 to 4 times daily
    ▪ massage until thoroughly absorbed into skin
    ▪ wash hands thoroughly with soap and water after each use
  • children under 12 years of age: ask a doctor

Inactive Ingredients



 

water, propanediol, steareth-21, alcohol denat., glyceryl stearate, cetyl alcohol, farnesol, stearic acid, aloe barbadensis leaf juice, acrylates/C10-30 alkyl acrylate crosspolymer, menthyl lactate, jojoba esters, diisopropyl adipate, pentylene glycol, 4-t-butylcyclohexanol, potassium hydroxide, 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, ferric ferrocyanide, citric acid

357-102

Close cap tightly after use.

Keep carton as it contains important information.


Principal Display Panel



IcyHot
Pro Pain Relief Cream

Net Wt 2 OZ (56 g)


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