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

Purpose

Topical anesthetic

Description

Lidocaine 4%


Medication Information

Warnings

For external use only

Purpose

Topical anesthetic

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

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

Description

Lidocaine 4%

Use

for the temporary relief of pain

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%

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

Warnings

For external use only

Purpose

Topical anesthetic

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

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

Use

for the temporary relief of pain

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%

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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