Icy Hot Max Pain Relief Patch

Icy Hot Max Pain Relief Patch
SPL v6
SPL
SPL Set ID 1830c5ce-60e2-40e7-96cb-c5f7b9357ae5
Route
TOPICAL
Published
Effective Date 2021-09-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (240 mg) Menthol, Unspecified Form (60 mg)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Anhydrous Aluminum Hydroxide Carboxymethylcellulose Sodium, Unspecified Form Glycerin Methylparaben Nonoxynol-30 Polysorbate 80 Propylene Glycol Silicon Dioxide Tartaric Acid Titanium Dioxide Urea Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-01-15

Description

Lidocaine 4% Menthol 1%

Purpose

Topical anesthetic Topical analgesic


Medication Information

Purpose

Topical anesthetic Topical analgesic

Description

Lidocaine 4% Menthol 1%

Use

for the temporary relief of pain

Purposes

Topical anesthetic

Topical analgesic

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
  • use 1 patch at a time and not more than 3 to 4 times daily

children under 12 years of age: consult a doctor

Do Not Use
  • on puncture wounds, cuts, irritated, damaged or swollen skin
  • more than 1 patch on your body at a time or with other topical analgesics at the same time
  • with a heating pad or apply local heat to the area of use
Active Ingredients

Lidocaine 4%

Menthol 1%

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

When Using This Product
  • use only as directed
  • do not bandage tightly
  • avoid contact with the eyes and mucous membranes
  • 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
  • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
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
  • severe burning sensation, redness, or irritation develops
  • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied
If Pregnant Or Breast Feeding,

ask a health professional before use.

Package/label Principal Display Panel

LIDOCAINE 4% + MENTHOL 1%

ICY HOT®

MAX

Pain Relief Patch

LIDOCAINE

PATCH

  • Maximum Strength Lidocaine

    Without a Prescription*
  • Penetrates for Fast, Targeted Relief
  • Comfortable Fabric
  • Stays in Place

*Among OTC Topical Analgesics

Contains 1 Patch

3-15/16” x 5-1/2” (10 cm x 14 cm)

CHATTEM®

A SANOFI COMPANY

Dist. by Chattem, Inc., a Sanofi Company

P.O. Box 2219

Chattanooga, TN 37409-0219 USA

©2020

www.icyhot.com     Made in Japan.

Label

Keep Out of Reach of Children and Pets.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Use

for the temporary relief of pain

Purposes

Topical anesthetic

Topical analgesic

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
  • use 1 patch at a time and not more than 3 to 4 times daily

children under 12 years of age: consult a doctor

Do Not Use (Do not use)
  • on puncture wounds, cuts, irritated, damaged or swollen skin
  • more than 1 patch on your body at a time or with other topical analgesics at the same time
  • with a heating pad or apply local heat to the area of use
Active Ingredients (Active ingredients)

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

When Using This Product (When using this product)
  • use only as directed
  • do not bandage tightly
  • avoid contact with the eyes and mucous membranes
  • 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
  • dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
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
  • severe burning sensation, redness, or irritation develops
  • you experience signs of skin injury, such as 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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

LIDOCAINE 4% + MENTHOL 1%

ICY HOT®

MAX

Pain Relief Patch

LIDOCAINE

PATCH

  • Maximum Strength Lidocaine

    Without a Prescription*
  • Penetrates for Fast, Targeted Relief
  • Comfortable Fabric
  • Stays in Place

*Among OTC Topical Analgesics

Contains 1 Patch

3-15/16” x 5-1/2” (10 cm x 14 cm)

CHATTEM®

A SANOFI COMPANY

Dist. by Chattem, Inc., a Sanofi Company

P.O. Box 2219

Chattanooga, TN 37409-0219 USA

©2020

www.icyhot.com     Made in Japan.

Label

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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