AUVON LIDOCAINE MENTHOL Pain Relief Patch

Drug Facts

Active ingredients

Lidocaine 4%

Menthol 1%

Purposes

Topical anesthetic

Topical analgesic

Use

for the temporary pain relief

Warnings

For external use only

Do not use

If you are allergic to the listed ingredients
If you are pregnent or breast feeding
If you are under 12 years of age
On wounds, cuts, damaged/broken/irritated skin
On eyes or mucous membranes
With heating pads/devices or wrap with a bandage
With other topical analgesics
If the package arrives damaged or opened.

When using this product

■ Use only as directed

■ Read and follow all directions and warnings on this label

■ avoid contact with the eyes and mucous membranes

■ rare cases of serious burns have been reported with products of this type

■ a transient burning sensation may occur upon application but generally disappears in several days

■ 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

You are experiencing pain, swelling or blistering

Redness is persent or irritation develops

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

Keep out of reach of children and pets.

If ingested, get medical help or contact a Poison Control Center

right away.

Directions

■ Clean and dry the patch application area (no wound or hair), pull to separate the film, peel off one side of the film, apply the exposed patch to the skin, peel off the other side of the film, and press the patch firmly to the skin.

■ Do not repeatedly use or repeatedly reapply the patch as far as possible

■ Cut first if if used on joints

■ Use in te affected area no more than 4 times daily

■ Wash hands with cool water after use

Storage

Avoid storing patches in direct sunlight
Protect patches from excessive moisture

Inactive ingredients

Glycerin, sodium polyacrylate, dihydroxyaluminum aminoacetate, methylparaben, propylparaben, polyacrylic acid, Kaolin, polysorbate 80, propylene glycol, tartaric acid, PVP, titanium dioxide, water

Label

AUVON LIDOCAINE MENTHOL PAIN RELIEF
lidocaine and menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:83391-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	370 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	100 mg

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
KAOLIN (UNII: 24H4NWX5CO)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:83391-001-01	1 in 1 CARTON; Type 0: Not a Combination Product	04/12/2023
2	NDC:83391-001-02	8 in 1 CARTON; Type 0: Not a Combination Product	04/12/2023
3	NDC:83391-001-03	30 in 1 CARTON; Type 0: Not a Combination Product	04/12/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	04/12/2023

Labeler - SHENZHEN YUWEN E-COMMERCE CO., LTD. (544559614)

Registrant - SHENZHEN YUWEN E-COMMERCE CO., LTD. (544559614)

Name	Address	ID/FEI	Business Operations
Establishment
Foshan Aqua Gel Biotech Co., Ltd.,		529128763	manufacture(83391-001)

83391-001