Icy Hot Lidocaine No-mess Liquid
FDA Label NDC 41167-1711

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 Lidocaine No-mess (NDC 41167-1711). 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, use, 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

Lidocaine HCl 4%............................................................................................................................Topical anesthetic

Use

for the temporary relief of pain

Warnings

For external use only

Flammable

  keep away from heat and open flame.

Do Not Use

 in large quantities 

 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 to direct sunlight

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 every 6 to 8 hours, 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

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol denat. (15%), aloe barbadensis leaf juice, aminomethyl propanol, C30-45 alkyl cetearyl dimethicone crosspolymer, caprylyl methicone, cetearyl alcohol, ceteth-20 phosphate, dicetyl phosphate, dimethicone, disodium EDTA, ethylhexylglycerin, glyceryl stearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, methylparaben, polysorbate 60, steareth-2, steareth-21, water

333-104

Child-resistant packaging. Close cap tightly after use.

Keep carton as it contains important information.

Principal Display Panel

Lidocaine 4%
Icy
 Hot
Max

Principal Display Panellidocaine 4%icyhotmax (Icy Hot Max Lidocaine No Mess No Menthol 01)

Principal Display Panellidocaine 4%icyhotmax (Icy Hot Max Lidocaine No Mess No Menthol 01)

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