AUVON PAIN RELIEF- menthol patch 
SHENZHEN YUWEN E-COMMERCE CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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83391-002

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

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,

image description

AUVON PAIN RELIEF 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83391-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL470 mg
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83391-002-011 in 1 POUCH; Type 0: Not a Combination Product07/05/2023
2NDC:83391-002-028 in 1 BOX; Type 0: Not a Combination Product07/05/2023
3NDC:83391-002-0315 in 1 BOX; Type 0: Not a Combination Product07/05/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34807/05/2023
Labeler - SHENZHEN YUWEN E-COMMERCE CO., LTD. (544559614)
Registrant - SHENZHEN YUWEN E-COMMERCE CO., LTD. (544559614)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(83391-002)

Revised: 7/2023
Document Id: ffc13112-3f8c-f071-e053-6394a90a7673
Set id: 9499f8f1-cb1d-444b-b646-bbbdc3550414
Version: 1
Effective Time: 20230705
 
SHENZHEN YUWEN E-COMMERCE CO., LTD.