Albertsons Signature Care Pain Relief Patch With 4% Lidocaine

Albertsons Signature Care Pain Relief Patch With 4% Lidocaine
SPL v2
SPL
SPL Set ID dc2823bb-8586-daca-e053-2995a90a2af0
Route
TOPICAL
Published
Effective Date 2022-04-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Petrolatum Carboxymethylcellulose Sodium, Unspecified Form Dihydroxyaluminum Aminoacetate Glycerin Kaolin Ethylhexylglycerin Polyacrylic Acid (8000 Mw) Polysorbate 80 Propylene Glycol Phenoxyethanol Povidone, Unspecified Sodium Polyacrylate (8000 Mw) Tartaric Acid Titanium Dioxide Water Iodopropynyl Butylcarbamate

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-04-01

Description

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Purpose

TOPICAL ANESTHETIC

Dosage and Administration

Directions Adults and children over 12 years: ■ clean and dry affected area ■ carefully remove backing from patch starting at a corner ■ apply sticky side of patch to affected area ■ use one patch for up to 12 hours. ■ Discard patch after single use ■ Children under 12 years of age: consult a physician.


Medication Information

Purpose

TOPICAL ANESTHETIC

Dosage and Administration

Directions Adults and children over 12 years:

■ clean and dry affected area

■ carefully remove backing from patch starting at a corner

■ apply sticky side of patch to affected area

■ use one patch for up to 12 hours.

■ Discard patch after single use

■ Children under 12 years of age: consult a physician.

Description

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Warnings

For external use only.

Questions

TOLL-FREE

Customer Care Help Line

1-888-423-0139

Mon–Fri 8:30 am–4:30 pm CST

DIST. BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

www.topcarebrand.com



Made in China

Do Not Use

■ more than one patch on your body at a time

■ on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

■ if you are allergic to any active or inactive ingredients

■ if pouch is damaged or opened.

Active Ingredients

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Idications and Usage

Uses: Temporaily relieves minor pains.

Inactive Ingredients

Aluminum Glycinate, Carboxymethylcellulose Sodium, Glycerin, iodopropynyl butylcarbamate, Kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, Povidone, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water, 3-(2-ethylhexyloxy) propane-1,2-diol.

When Using This Product

■ use only as directed

■ read and follow all directions and warnings on this carton

■ do not allow contact with the eyes

■ do not use at the same time as other topical analgesics

■ do not bandage tightly or apply local heat (such as heating pads) to the area of use

■ do not microwave

■ 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.

Other Safety Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Stop Use and Consult A Doctor

■ condition worsens

■ redness is present

■ irritation develops

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

■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

Keep Out of Reach of Children and Pets.

If swallowed, get medical help or contact a Poison Control Center at 1-800-222-222 right away.

Albertsons Pain Relief Patch With 4% Lidocaine


Structured Label Content

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Purpose

TOPICAL ANESTHETIC

Warnings

For external use only.

Questions

TOLL-FREE

Customer Care Help Line

1-888-423-0139

Mon–Fri 8:30 am–4:30 pm CST

DIST. BY

TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

www.topcarebrand.com



Made in China

Do Not Use (Do not Use)

■ more than one patch on your body at a time

■ on cut, irritated or swollen skin

■ on puncture wounds

■ for more than one week without consulting a doctor

■ if you are allergic to any active or inactive ingredients

■ if pouch is damaged or opened.

Active Ingredients

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Idications and Usage

Uses: Temporaily relieves minor pains.

Inactive Ingredients

Aluminum Glycinate, Carboxymethylcellulose Sodium, Glycerin, iodopropynyl butylcarbamate, Kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, Povidone, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water, 3-(2-ethylhexyloxy) propane-1,2-diol.

When Using This Product (When using this product)

■ use only as directed

■ read and follow all directions and warnings on this carton

■ do not allow contact with the eyes

■ do not use at the same time as other topical analgesics

■ do not bandage tightly or apply local heat (such as heating pads) to the area of use

■ do not microwave

■ 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.

Other Safety Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Dosage and Administration

Directions Adults and children over 12 years:

■ clean and dry affected area

■ carefully remove backing from patch starting at a corner

■ apply sticky side of patch to affected area

■ use one patch for up to 12 hours.

■ Discard patch after single use

■ Children under 12 years of age: consult a physician.

Stop Use and Consult A Doctor (Stop use and consult a doctor)

■ condition worsens

■ redness is present

■ irritation develops

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

■ you experience signs of skin injury, such as pain, swelling or blistering where the product was applied.

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

If swallowed, get medical help or contact a Poison Control Center at 1-800-222-222 right away.

Albertsons Pain Relief Patch With 4% Lidocaine (Albertsons Pain Relief Patch with 4% Lidocaine)


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