SPL v1
SPL
SPL Set ID 2611c2c5-dfb1-9ccd-e063-6394a90a1ee9
Route
TOPICAL
Published
Effective Date 2024-11-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 mg)
Inactive Ingredients
Propylene Glycol Dihydroxyaluminum Aminoacetate Propylparaben Titanium Dioxide Glycerin Tartaric Acid Polyacrylic Acid (250000 Mw) Povidone K90 Methylparaben Magnesium Disodium Edta Sodium Polyacrylate (2500000 Mw) Kaolin Water Polysorbate 80

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-04

Description

Lidocaine 4%

Purpose

Desensitizes AggravatedNerves And Relieves Pain : No lrritation Stay-put Flexible Patch Numbs Pain Away


Medication Information

Purpose

Desensitizes AggravatedNerves And Relieves Pain : No lrritation Stay-put Flexible Patch Numbs Pain Away

Description

Lidocaine 4%

Dosage

take an appropriateamount,Use 2-3 times a week

Section 51945-4

Warning

For external use only

Not Use

Not suitable for use by children, pregnantor breast feeding people.

Stop Use

on wounds or damaged skin

with a heating pad or devic

with other ointments, creams,sprays, or liniments

if your are allergic to any ingredients of this product

How to Use

Adults and Children above 12 year sold:

Clean and dry the affected area.

Tear off the protective film andapply the exposed part of the patch tothe affected area.

Carefully remove remaining film while pressing the patch firmly on theskin.patch firmly on the skin.

Remove patch from the skin afterat most 8-hour application

Purpose Section

Desensitizes AggravatedNerves And Relieves Pain :

No lrritation

Stay-put Flexible Patch

Numbs Pain Away

Active Ingredients

Lidocaine 4%

Inactive Ingredients

Glycerin, Sodium Polyacrylate,Dihydroxyaluminum Aminoacetate,Disodium EthylenediaminetetraaceticAcid, Kaolin, Titanium Dioxide,Poly-sorbate 80, Propylene Glycol, TartaricAcid, Polyacrylic Acid,Polyvinylpyrroli-done K90, Methylparaben,Propylpara-ben, Water.

Keep Out of Reach of Children.

If swallowed accidentally , get medical help or contact with Poison Control Center immediately.


Structured Label Content

Dosage

take an appropriateamount,Use 2-3 times a week

Section 51945-4 (51945-4)

Warning

For external use only

Not Use (not use)

Not suitable for use by children, pregnantor breast feeding people.

Stop Use (stop use)

on wounds or damaged skin

with a heating pad or devic

with other ointments, creams,sprays, or liniments

if your are allergic to any ingredients of this product

How to Use (HOW TO USE)

Adults and Children above 12 year sold:

Clean and dry the affected area.

Tear off the protective film andapply the exposed part of the patch tothe affected area.

Carefully remove remaining film while pressing the patch firmly on theskin.patch firmly on the skin.

Remove patch from the skin afterat most 8-hour application

Purpose Section (Purpose section)

Desensitizes AggravatedNerves And Relieves Pain :

No lrritation

Stay-put Flexible Patch

Numbs Pain Away

Active Ingredients (Active ingredients)

Lidocaine 4%

Inactive Ingredients (Inactive ingredients)

Glycerin, Sodium Polyacrylate,Dihydroxyaluminum Aminoacetate,Disodium EthylenediaminetetraaceticAcid, Kaolin, Titanium Dioxide,Poly-sorbate 80, Propylene Glycol, TartaricAcid, Polyacrylic Acid,Polyvinylpyrroli-done K90, Methylparaben,Propylpara-ben, Water.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed accidentally , get medical help or contact with Poison Control Center immediately.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)