AUVON PAIN RELIEF- menthol patch

AUVON Pain Relief by

Drug Labeling and Warnings

AUVON Pain Relief by is a Otc medication manufactured, distributed, or labeled by SHENZHEN YUWEN E-COMMERCE CO., LTD., Foshan Aqua Gel Biotech Co., Ltd.,. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

MENTHOL AUVON Pain Relief Patch

Drug Facts

Active ingredients

Menthol 5%

Purposes

Topical Analgestic

Use

Temporary relief from minor aches and paons of sore muscles and joints

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

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 outof 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, CMC, mineral oil, petrolatum,

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AUVON PAIN RELIEF 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83391-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	470 mg

Inactive Ingredients
Ingredient Name	Strength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)
GLYCERIN (UNII: PDC6A3C0OX)
METHYLPARABEN (UNII: A2I8C7HI9T)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TARTARIC ACID (UNII: W4888I119H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
WATER (UNII: 059QF0KO0R)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
KAOLIN (UNII: 24H4NWX5CO)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83391-002-01	1 in 1 POUCH; Type 0: Not a Combination Product	07/05/2023
2	NDC: 83391-002-02	8 in 1 BOX; Type 0: Not a Combination Product	07/05/2023
3	NDC: 83391-002-03	15 in 1 BOX; Type 0: Not a Combination Product	07/05/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/05/2023

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.,		529128763	manufacture(83391-002)