ALBERTSON LIDOCAINE, MENTHOL PAIN RELIEF MEDICATED PATCH- lidocaine and menthol patch

Albertson Lidocaine, Menthol Pain Relief Medicated Patch by

Drug Labeling and Warnings

Albertson Lidocaine, Menthol Pain Relief Medicated Patch by is a Otc medication manufactured, distributed, or labeled by Safeway, Foshan Aqua Gel Biotech Co., Ltd.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Lidocaine 4%

Menthol 1%

Purposes

Topical anesthetic

Topical analgesic

Use

for the temporary relief minor pain

Warnings

For external use only

Do not use

■ more than 1 patch on your body at a time

■ on a 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 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.

Stop use and ask a doctor if

■ 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 pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding,

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 800-222-1222 right away.

Directions

adults and children 12 years of age and older:

■ clean and dry affected area

■ Carefully remove backing from patch starting at a corner

■ Apply sticky side of patch to affected area

■ use 1 patch for up to 12 hours

■ Discard patch after single use

children under 12 years of age: consult a physician

Inactive ingredients

carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2ethylhexyloxy)propane-1,2-diol.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALBERTSON LIDOCAINE, MENTHOL PAIN RELIEF MEDICATED PATCH 
lidocaine and menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-961
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
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1 g  in 100 g

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-961-05	5 g in 1 CARTON; Type 0: Not a Combination Product	04/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/01/2022

Labeler - Safeway (009137209)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.,		529128763	manufacture(21130-961)