Label: AUVON PAIN RELIEF- menthol patch
- NDC Code(s): 83391-002-01, 83391-002-02, 83391-002-03
- Packager: SHENZHEN YUWEN E-COMMERCE CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated July 5, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purposes
- Use
-
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
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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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
AUVON PAIN RELIEF
menthol patchProduct 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)
