WELMATE LIDOCAINE PAIN RELIEVING PATCH- lidocaine patch

Welmate Lidocaine Pain Relieving Patch by

Drug Labeling and Warnings

Welmate Lidocaine Pain Relieving Patch by is a Otc medication manufactured, distributed, or labeled by Yyba Corporation, Foshan Aqua Gel Biotech Co., Ltd.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Uses

For temporary 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 directions and warnings on this carton
• do not allow contact with 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

• conditions worsen
• 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 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 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, polysorbate80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

Questions or comments?

Toll free 866-933-6337 www.salonpas.us

Principal Display Panel

INGREDIENTS AND APPEARANCE

WELMATE LIDOCAINE PAIN RELIEVING PATCH 
lidocaine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73581-911
Route of Administration	TOPICAL, PERCUTANEOUS, TRANSDERMAL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73581-911-30	30 in 1 CARTON	11/01/2021
1		11 g in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 73581-911-15	15 in 1 CARTON	09/01/2022
2		11 g in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/01/2021

Labeler - Yyba Corporation (006339772)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.,		529128763	manufacture(73581-911)