Aspercreme Lidocaine Patch

Aspercreme Lidocaine Patch
SPL v9
SPL
SPL Set ID 7ad8efa9-7031-4cd0-be1d-6dee63091fd1
Route
TOPICAL
Published
Effective Date 2026-01-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Aluminum Glycinate Aluminum Hydroxide Cellulose Gum Glycerin Methylparaben Nonoxynol-30 Polyacrylic Acid (250000 Mw) Polysorbate 80 Propylene Glycol Silicon Dioxide Sodium Polyacrylate (8000 Mw) Tartaric Acid Titanium Dioxide Urea Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-02-01

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

   ■ 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

■ 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

Active Ingredien

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

Principal Display Pane

Aspercreme

with 4% Lidocaine

PAIN RELIEVING PATCH

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

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.

Keep Out of Reach of Children and Pets.

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.


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

   ■ 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 (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

Active Ingredien (Active ingredien)

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

Principal Display Pane (PRINCIPAL DISPLAY PANE)

Aspercreme

with 4% Lidocaine

PAIN RELIEVING PATCH

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

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.

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

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.


Advanced Ingredient Data


Raw Label Data

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