Icy Hot with Lidocaine LIDOCAINE AND MENTHOL CHATTEM, INC. FDA Approved Use for the temporary relief of pain
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Substance Lidocaine
Route
TOPICAL
Applications
505G(A)(3)
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active i ngredient s Lidocaine 4% Menthol 1%
Inactive Ingredients
Inactive ingredients aluminum glycinate aluminum hydroxide cellulose gum glycerin methyl acrylate/2-ethylhexyl acrylate copolymer methylparaben nonoxynol-30 polyacrylic acid polysorbate 80 propylene glycol silica sodium polyacrylate tartaric acid titanium dioxide urea water Child-resistant packaging . Keep carton as it contains important information.
Strengths
4 % 1 %
Treats Conditions
Use For The Temporary Relief Of Pain

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
98PI200987 L7T10EIP3A
Packaging

PRINCIPAL DISPLAY PANEL ICYHOT with LIDOCAINE LARGE PATCH PAIN RELIEF 4% LIDOCAINE + 1% MENTHOL ICYHOT with LIDOCAINE LARGE PATCH PAIN RELIEF 4% LIDOCAINE + 1% MENTHOL

Package Descriptions
  • PRINCIPAL DISPLAY PANEL ICYHOT with LIDOCAINE LARGE PATCH PAIN RELIEF 4% LIDOCAINE + 1% MENTHOL ICYHOT with LIDOCAINE LARGE PATCH PAIN RELIEF 4% LIDOCAINE + 1% MENTHOL

Overview

Use for the temporary relief of pain

Indications & Usage

Use for the temporary relief of pain

Dosage & Administration

Directions adults and children 12 years of age and older: ■ clean and dry affected area ■ remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle ■ carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area ■ once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area ■ apply to the affected area not more than 3 to 4 times daily ■ wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. children under 12 years of age: consult a doctor

Warnings & Precautions
Warnings For external use only Do not use ■ on wounds or on irritated or damaged skin ■ more than 1 patch on your body at a time or with other topical analgesics at the same time ■ 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 ■ 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 and pets. Used patches may still contain the drug product that can produce serious adverse effects if ingested by children or pets. If swallowed, get medical help or contact a Poison Control Center right away.
Purpose

Purpose s Topical anesthetic Topical analgesic

Do Not Use

Do not use ■ on wounds or on irritated or damaged skin ■ more than 1 patch on your body at a time or with other topical analgesics at the same time ■ with a heating pad

When Using

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 ■ 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 & Ask a Doctor

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

Keep out of reach of children and pets. Used patches may still contain the drug product that can produce serious adverse effects if ingested by children or pets. If swallowed, get medical help or contact a Poison Control Center right away.


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