Icy Hot With Lidocaine Patch

Icy Hot With Lidocaine Patch
SPL v7
SPL
SPL Set ID 267c0070-f65e-4faf-b10e-9f7f2393b9e2
Route
TOPICAL
Published
Effective Date 2025-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (240 mg) Menthol (60 mg)
Inactive Ingredients
Aluminum Glycinate Aluminum Hydroxide Cellulose Gum Glycerin Methylparaben Nonoxynol-30 2-ethylhexyl Acrylate Polyacrylic Acid (250000 Mw) Polysorbate 80 Propylene Glycol Silicon Dioxide Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide Urea Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-02-18

Description

ICY HOT   with 4% LIDOCAINE   PATCH Drug Facts

Purpose

Topical anesthetic Topical analgesic


Medication Information

Purpose

Topical anesthetic

Topical analgesic

Description

ICY HOT   with 4% LIDOCAINE   PATCH Drug Facts

Use

for the temporary relief of pain

Section 42229-5

ICY HOT   with 4% LIDOCAINE   PATCH

Drug Facts

Active I

Lidocaine 4%

Menthol 1%

Keep Out

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.

Warnings

For external use only

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

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

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.

Principal Display Panel

ICYHOT

with LIDOCAINE

LARGE PATCH

PAIN RELIEF

4% LIDOCAINE +

1% MENTHOL

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.


Structured Label Content

Use

for the temporary relief of pain

Section 42229-5 (42229-5)

ICY HOT   with 4% LIDOCAINE   PATCH

Drug Facts

Purpose

Topical anesthetic

Topical analgesic

Active I (Active i)

Lidocaine 4%

Menthol 1%

Keep Out (Keep out)

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.

Warnings

For external use only

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

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

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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ICYHOT

with LIDOCAINE

LARGE PATCH

PAIN RELIEF

4% LIDOCAINE +

1% MENTHOL

When Using This Product (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 (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, (If pregnant or breast-feeding,)

ask a health professional before use.


Advanced Ingredient Data


Raw Label Data

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