Amazon Basics Pain Relief Patch With 4% Lidocaine

Amazon Basics Pain Relief Patch With 4% Lidocaine
SPL v5
SPL
SPL Set ID e3b4f9b1-ac6b-cb2a-e053-2a95a90a9e1e
Route
TOPICAL
Published
Effective Date 2023-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Description

Lidocaine 4.0%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4.0%

Use

Temporarily relieves minor pain.

Warnings

For external use only

Directions

Adults and children 12 years of age and over: 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.

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 Ingredient

Lidocaine 4.0%

Other Information

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

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 lightly 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.

If Pregnant Or Breastfeeding

ask a health professional before use

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 1-800-222-1222 right away.

Amazon Basics Pain Relief Patch With 4% Lidocaine, 15 Ct


Structured Label Content

Use

Temporarily relieves minor pain.

Purpose

Topical anesthetic

Warnings

For external use only

Directions

Adults and children 12 years of age and over: 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.

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 Ingredient

Lidocaine 4.0%

Other Information

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

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 lightly 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.

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use

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 1-800-222-1222 right away.

Amazon Basics Pain Relief Patch With 4% Lidocaine, 15 Ct (Amazon Basics Pain Relief Patch with 4% Lidocaine, 15 ct)


Advanced Ingredient Data


Raw Label Data

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