Pain Relieving Patch

Pain Relieving Patch
SPL v7
SPL
SPL Set ID fd0df32c-7cbd-8c80-e053-6394a90ac589
Route
TOPICAL
Published
Effective Date 2023-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 mg)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Anhydrous Propylene Glycol Polyacrylic Acid (250000 Mw) Tartaric Acid Methyl Acrylate Alcohol Water Glycerin Polysorbate 80 Polyvinyl Alcohol (18000 Mw) Sodium Polyacrylate (2500000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-01

Description

LIDOCAINE PATCH 4%


Medication Information

Warnings and Precautions

For external use only

Do not use more than 1 patch on vour bodv at a time on cut, irritated.or swolen skin on puncture wounds

for more than one week without consulting a doctor

Indications and Usage

LIDOCAINE PATCH to help Temporarily relteves minor pain

Dosage and Administration

Adults and children 12 years of age and older:

Wash and dry the affected area.

Peel off the backing film from one side of the patch carefully

Apply the exposed portion of the patch to the affected area.

Gently press the patch with your hand to fit the affected area completely.

Do not exercise vigorously during use to prevent the patch from falling off.

Use only 1 patch for a maximum of 8 hours.

Children under 12 years of age: Ask a doctor before use.

Description

LIDOCAINE PATCH 4%

Section 42229-5

LIDOCAINE PATCH 4%

Section 44425-7

store at room temperature 15°-30°C (59°-86°F)

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222).

Section 50566-9

condition worsens

symptoms persist for more than 7 days or clear up and occur again within a few days

redness or iritation develops you experience signs of skin injury, such as pain, swelling, or blistering where

the product was applied

Section 50567-7

use onlv as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes

do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analcesics

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.

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

Section 50570-1

use onlv as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes

do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analcesics

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.

Section 51727-6

aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol.

sodium polvacrylate, tartaric acid, poval, alcohol, water

Section 51945-4

Section 55105-1

For the temporary relief of pain

Section 55106-9

Lidocaine 4% Topical anesthetic


Structured Label Content

Indications and Usage (34067-9)

LIDOCAINE PATCH to help Temporarily relteves minor pain

Dosage and Administration (34068-7)

Adults and children 12 years of age and older:

Wash and dry the affected area.

Peel off the backing film from one side of the patch carefully

Apply the exposed portion of the patch to the affected area.

Gently press the patch with your hand to fit the affected area completely.

Do not exercise vigorously during use to prevent the patch from falling off.

Use only 1 patch for a maximum of 8 hours.

Children under 12 years of age: Ask a doctor before use.

Warnings and Precautions (34071-1)

For external use only

Do not use more than 1 patch on vour bodv at a time on cut, irritated.or swolen skin on puncture wounds

for more than one week without consulting a doctor

Section 42229-5 (42229-5)

LIDOCAINE PATCH 4%

Section 44425-7 (44425-7)

store at room temperature 15°-30°C (59°-86°F)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away(1-800-222-1222).

Section 50566-9 (50566-9)

condition worsens

symptoms persist for more than 7 days or clear up and occur again within a few days

redness or iritation develops you experience signs of skin injury, such as pain, swelling, or blistering where

the product was applied

Section 50567-7 (50567-7)

use onlv as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes

do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analcesics

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.

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

Section 50570-1 (50570-1)

use onlv as directed. Read and follow all directions and warnings on this carton. do not allow contact with the eyes

do not bandage tightly or apply local heat (such as heating pads) to the area of use do not use at the same time as other topical analcesics

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.

Section 51727-6 (51727-6)

aluminum glycinate, glycerin, methyl acrylate, polyacrylic acid, polysorbate 80, propylene glycol.

sodium polvacrylate, tartaric acid, poval, alcohol, water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For the temporary relief of pain

Section 55106-9 (55106-9)

Lidocaine 4% Topical anesthetic


Advanced Ingredient Data


Raw Label Data

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