Aspercreme Lidocaine Patch

Aspercreme Lidocaine Patch
SPL v8
SPL
SPL Set ID 275e1343-deef-424a-a883-5e780083af91
Route
TOPICAL
Published
Effective Date 2024-01-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (246 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 Completed Since 2016-02-16 Until 2025-03-31

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Use – Lidocaine Patch Us 1ct

for the temporary relief of pain

Purpose – Lidocaine Patch Us 1ct

Topical anesthetic

Warnings – Lidocaine Patch Us 1ct

For external use only

Directions – Lidocaine Patch Us 1ct

•   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 after folding sticky ends together.

•   children under 12 years of age: ask a doctor

Do Not Use – Lidocaine Patch Us 1ct
  • on wounds or on irritated or damage skin
  • more than 1 patch on your body at a time or with other topical analgesics at the same time
  • with a heating pad
Use – Lidocaine Patch Singles Us 1ct

For the temporarily relief of pain

Purpose – Lidocaine Patch Singles Us 1ct

Topical anesthetic

Warnings – Lidocaine Patch Singles Us 1ct

For external use only

Active Ingredient – Lidocaine Patch Us 1ct

Lidocaine 4%

Directions – Lidocaine Patch Singles Us 1ct

adults and children over 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 – Lidocaine Patch Singles Us 1ct
  • 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
Inactive Ingredients – Lidocaine Patch Us 1ct

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 – Lidocaine Patch Us 1ct
  • use only as directed
  • do not bandage tightly
  • avoid contact with the eyes and mucous membranes
  • do not expose the area to local heat or to direct sunlight
Active Ingredient – Lidocaine Patch Singles Us 1ct

Lidocaine 4%

Inactive Ingredients – Lidocaine Patch Singles Us 1ct

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

Stop Use and Ask A Doctor If – Lidocaine Patch Us 1ct
  • 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, – Lidocaine Patch Us 1ct

ask a health professional before use.

When Using This Product – Lidocaine Patch Singles Us 1ct
  • 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 or 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 – Lidocaine Patch Singles Us 1ct
  • 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
Package/label Principal Display Panel – Lidocaine Patch Us 1ct

MAX STRENGTH

Aspercreme®with 4% LIDOCAINE

PAIN RELIEF PATCH

NUMBS AWAY PAINFAST ACTING

TARGETS NERVES

FLEXIBLE FABRIC

#1 LIDOCAINE BRAND*

PATCH

FRAGRANCE-FREE

Contains 1 Patch 3-15/16” x 5-1/2” (10 cm x 14 cm)

Pain Relieving Ointment on a Breathable Adhesive Pad

*Among OTC topical analgesics.



Dist. by Chattem, Inc., a Sanofi Company

P.O. Box 2219, Chattanooga, TN

37409-0219 USA

©2022

www.aspercreme.com     Made in Japan

Label

If Pregnant Or Breast Feeding, – Lidocaine Patch Singles Us 1ct

ask a health professional before use.

Keep Out of Reach of Children and Pets. – Lidocaine Patch Us 1ct

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.

Package/label Principal Display Panel – Lidocaine Patch Singles Us 1ct

MAX STRENGTH

Aspercreme®with 4% LIDOCAINE

PAIN RELIEF PATCH

NUMBS AWAY PAINFAST ACTING

TARGETS NERVES

FLEXIBLE FABRIC

#1 LIDOCAINE BRAND*

PATCH

FRAGRANCE-FREE

Contains 1 Patch 3-15/16” x 5-1/2” (10 cm x 14 cm)

Pain Relieving Ointment on a Breathable Adhesive Pad

*Among OTC topical analgesics



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. – Lidocaine Patch Singles Us 1ct

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


Structured Label Content

Use – Lidocaine Patch Us 1ct (Use – Lidocaine Patch US 1ct)

for the temporary relief of pain

Purpose – Lidocaine Patch Us 1ct (Purpose – Lidocaine Patch US 1ct)

Topical anesthetic

Warnings – Lidocaine Patch Us 1ct (Warnings – Lidocaine Patch US 1ct)

For external use only

Directions – Lidocaine Patch Us 1ct (Directions – Lidocaine Patch US 1ct)

•   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 after folding sticky ends together.

•   children under 12 years of age: ask a doctor

Do Not Use – Lidocaine Patch Us 1ct (Do not use – Lidocaine Patch US 1ct)
  • on wounds or on irritated or damage skin
  • more than 1 patch on your body at a time or with other topical analgesics at the same time
  • with a heating pad
Use – Lidocaine Patch Singles Us 1ct (Use – Lidocaine Patch Singles US 1ct)

For the temporarily relief of pain

Purpose – Lidocaine Patch Singles Us 1ct (Purpose – Lidocaine Patch Singles US 1ct)

Topical anesthetic

Warnings – Lidocaine Patch Singles Us 1ct (Warnings – Lidocaine Patch Singles US 1ct)

For external use only

Active Ingredient – Lidocaine Patch Us 1ct (Active ingredient – Lidocaine Patch US 1ct)

Lidocaine 4%

Directions – Lidocaine Patch Singles Us 1ct (Directions – Lidocaine Patch Singles US 1ct)

adults and children over 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 – Lidocaine Patch Singles Us 1ct (Do not use – Lidocaine Patch Singles US 1ct)
  • 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
Inactive Ingredients – Lidocaine Patch Us 1ct (Inactive ingredients – Lidocaine Patch US 1ct)

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 – Lidocaine Patch Us 1ct (When using this product – Lidocaine Patch US 1ct)
  • use only as directed
  • do not bandage tightly
  • avoid contact with the eyes and mucous membranes
  • do not expose the area to local heat or to direct sunlight
Active Ingredient – Lidocaine Patch Singles Us 1ct (Active ingredient – Lidocaine Patch Singles US 1ct)

Lidocaine 4%

Inactive Ingredients – Lidocaine Patch Singles Us 1ct (Inactive ingredients – Lidocaine Patch Singles US 1ct)

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

Stop Use and Ask A Doctor If – Lidocaine Patch Us 1ct (Stop use and ask a doctor if – Lidocaine Patch US 1ct)
  • 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, – Lidocaine Patch Us 1ct (If pregnant or breast-feeding, – Lidocaine Patch US 1ct)

ask a health professional before use.

When Using This Product – Lidocaine Patch Singles Us 1ct (When using this product – Lidocaine Patch Singles US 1ct)
  • 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 or 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 – Lidocaine Patch Singles Us 1ct (Stop use and ask a doctor if – Lidocaine Patch Singles US 1ct)
  • 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
Package/label Principal Display Panel – Lidocaine Patch Us 1ct (Package/Label Principal Display Panel – Lidocaine Patch US 1ct)

MAX STRENGTH

Aspercreme®with 4% LIDOCAINE

PAIN RELIEF PATCH

NUMBS AWAY PAINFAST ACTING

TARGETS NERVES

FLEXIBLE FABRIC

#1 LIDOCAINE BRAND*

PATCH

FRAGRANCE-FREE

Contains 1 Patch 3-15/16” x 5-1/2” (10 cm x 14 cm)

Pain Relieving Ointment on a Breathable Adhesive Pad

*Among OTC topical analgesics.



Dist. by Chattem, Inc., a Sanofi Company

P.O. Box 2219, Chattanooga, TN

37409-0219 USA

©2022

www.aspercreme.com     Made in Japan

Label

If Pregnant Or Breast Feeding, – Lidocaine Patch Singles Us 1ct (If pregnant or breast feeding, – Lidocaine Patch Singles US 1ct)

ask a health professional before use.

Keep Out of Reach of Children and Pets. – Lidocaine Patch Us 1ct (Keep out of reach of children and pets. – Lidocaine Patch US 1ct)

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.

Package/label Principal Display Panel – Lidocaine Patch Singles Us 1ct (Package/Label Principal Display Panel – Lidocaine Patch Singles US 1ct)

MAX STRENGTH

Aspercreme®with 4% LIDOCAINE

PAIN RELIEF PATCH

NUMBS AWAY PAINFAST ACTING

TARGETS NERVES

FLEXIBLE FABRIC

#1 LIDOCAINE BRAND*

PATCH

FRAGRANCE-FREE

Contains 1 Patch 3-15/16” x 5-1/2” (10 cm x 14 cm)

Pain Relieving Ointment on a Breathable Adhesive Pad

*Among OTC topical analgesics



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. – Lidocaine Patch Singles Us 1ct (Keep out of reach of children and pets. – Lidocaine Patch Singles US 1ct)

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


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