Lidocaine Pain Relief Patch

Lidocaine Pain Relief Patch
SPL v3
SPL
SPL Set ID 2014b858-98da-bb7f-e063-6394a90a85b1
Route
TOPICAL
Published
Effective Date 2024-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Edetate Disodium Polyvinyl Alcohol, Unspecified Dihydroxyaluminum Aminoacetate Carboxymethylcellulose Sodium, Unspecified Glycerin Sodium Polyacrylate (2500000 Mw) Methylparaben Propylene Glycol Tartaric Acid Propylparaben Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-08-20

Description

Lidocaine Pain Relief Patch


Medication Information

Warnings and Precautions

For external use only.

Indications and Usage

For the temporary relief of pain.

Dosage and Administration

Adults and children 12 years of age and older:

Clean and dry the affected area

Apply a patch at a time to the affected area; not more than 3 or 4times daily to the affected area

Remove the patch from the skin after at most 8 hours of application

Children under 12 years of age: consult a doctor.

Description

Lidocaine Pain Relief Patch

Section 42229-5

Lidocaine Pain Relief Patch

Section 44425-7

Store at 20-25°C(68-77°F)and protect from moisture.

Section 50565-1

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

If pregnant or breast-feeding, ask a health professional before use

Section 50566-9

Stop use and ask a doctor if localized skin reactions occur,such as rash, itching, redness, irritation condition worsens, or if symptoms persist for more than 7 days or clear up and occur againwithin a few days.

Section 50567-7

Avoid contact with the eyes When using this product

Section 50570-1

Do not use more than 1 patch at a time on wounds or damagedskin with a heating pad lf you are allergic to any ingredients ofthis product

Section 51727-6

dihydroxyaluminium aminoacetate

disodium EDTA

Methylparaben

polyvinyl alcohol

propylene glycol

sodium carboxymethyl cellulose

sodium polyacrylate

propyl paraben

titanium dioxide

tartaric acid

Glycerin

purified water

Section 51945-4

Section 55105-1

Topical Anesthetic

Section 55106-9

Lidocaine 4%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of pain.

Dosage and Administration (34068-7)

Adults and children 12 years of age and older:

Clean and dry the affected area

Apply a patch at a time to the affected area; not more than 3 or 4times daily to the affected area

Remove the patch from the skin after at most 8 hours of application

Children under 12 years of age: consult a doctor.

Warnings and Precautions (34071-1)

For external use only.

Section 42229-5 (42229-5)

Lidocaine Pain Relief Patch

Section 44425-7 (44425-7)

Store at 20-25°C(68-77°F)and protect from moisture.

Section 50565-1 (50565-1)

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

If pregnant or breast-feeding, ask a health professional before use

Section 50566-9 (50566-9)

Stop use and ask a doctor if localized skin reactions occur,such as rash, itching, redness, irritation condition worsens, or if symptoms persist for more than 7 days or clear up and occur againwithin a few days.

Section 50567-7 (50567-7)

Avoid contact with the eyes When using this product

Section 50570-1 (50570-1)

Do not use more than 1 patch at a time on wounds or damagedskin with a heating pad lf you are allergic to any ingredients ofthis product

Section 51727-6 (51727-6)

dihydroxyaluminium aminoacetate

disodium EDTA

Methylparaben

polyvinyl alcohol

propylene glycol

sodium carboxymethyl cellulose

sodium polyacrylate

propyl paraben

titanium dioxide

tartaric acid

Glycerin

purified water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Anesthetic

Section 55106-9 (55106-9)

Lidocaine 4%


Advanced Ingredient Data


Raw Label Data

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