Aspercreme Lidocaine Xl Patch

Aspercreme Lidocaine Xl Patch
SPL v5
SPL
SPL Set ID b1077b76-7ae7-4b1b-a972-c1b10e9671f9
Route
TOPICAL
Published
Effective Date 2021-06-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (411.4 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 2017-10-15

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Use

for the temporary relief of pain

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 12 years or younger: consult a doctor

Do Not Use
  • on puncture wounds, cuts, irritated 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 Ingredient

Lidocaine 4%

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
  • 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
  • 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

MAX STRENGTH

Aspercreme®

with 4% LIDOCAINE

PAIN RELIEF PATCH

NUMBS AWAY PAIN

FAST ACTING

TARGETS NERVES

FLEXIBLE FABRIC



#1 LIDOCAINE BRAND*

XL PATCH

71% LARGER

FRAGRANCE-FREE

Contains 1 Patch 4-¾” x 7-7/8” (12 cm x 20 cm)

Pain Relieving Ointment on a Breathable Adhesive Pad

*Among OTC topical analgesics.

Than 10 cm x 14 cm Aspercreme® patches.



CHATTEM®

A SANOFI COMPANY

Dist. By Chattem, Inc., a Sanofi Company

P.O. Box 2219, Chattanooga, TN

37409-0219 USA

©2020

www.aspercreme.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

Purpose

Topical anesthetic

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 12 years or younger: consult a doctor

Do Not Use (Do not use)
  • on puncture wounds, cuts, irritated 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 Ingredient (Active ingredient)

Lidocaine 4%

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
  • 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
  • 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)

MAX STRENGTH

Aspercreme®

with 4% LIDOCAINE

PAIN RELIEF PATCH

NUMBS AWAY PAIN

FAST ACTING

TARGETS NERVES

FLEXIBLE FABRIC



#1 LIDOCAINE BRAND*

XL PATCH

71% LARGER

FRAGRANCE-FREE

Contains 1 Patch 4-¾” x 7-7/8” (12 cm x 20 cm)

Pain Relieving Ointment on a Breathable Adhesive Pad

*Among OTC topical analgesics.

Than 10 cm x 14 cm Aspercreme® patches.



CHATTEM®

A SANOFI COMPANY

Dist. By Chattem, Inc., a Sanofi Company

P.O. Box 2219, Chattanooga, TN

37409-0219 USA

©2020

www.aspercreme.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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