AMAZON BASICS PAIN RELIEF PATCH WITH 4% LIDOCAINE- lidocaine patch

Amazon Basics Pain Relief Patch with 4% Lidocaine by

Drug Labeling and Warnings

Amazon Basics Pain Relief Patch with 4% Lidocaine by is a Otc medication manufactured, distributed, or labeled by Amazon.com Services LLC, Foshan Aqua Gel Biotech Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Lidocaine 4.0%

Purpose

Topical anesthetic

Use

Temporarily relieves minor pain.

Warnings

For external use only

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

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.

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.

If pregnant or breastfeeding

ask a health professional before use

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.

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.

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

Amazon Basics Pain Relief Patch with 4% Lidocaine, 15 ct

INGREDIENTS AND APPEARANCE

AMAZON BASICS PAIN RELIEF PATCH WITH 4% LIDOCAINE 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72288-967
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
KAOLIN (UNII: 24H4NWX5CO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TARTARIC ACID (UNII: W4888I119H)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
POVIDONE (UNII: FZ989GH94E)
PETROLATUM (UNII: 4T6H12BN9U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72288-967-15	15 in 1 CARTON	01/01/2023
1		1 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/01/2023

Labeler - Amazon.com Services LLC (128990418)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.		529128763	manufacture(72288-967)