Label: AUVON LIDOCAINE MENTHOL PAIN RELIEF PATCH- lidocaine and menthol patch
- NDC Code(s): 83391-008-01, 83391-008-02, 83391-008-03
- Packager: SHENZHEN YUWEN E-COMMERCE CO., LTD.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 20, 2025
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
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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.
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WHEN USING
■ 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
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
■ 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 ■ 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 AND HANDLING
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
AUVON LIDOCAINE MENTHOL PAIN RELIEF PATCH
lidocaine and menthol patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:83391-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOMENTHOL (UNII: BZ1R15MTK7) (LEVOMENTHOL - UNII:BZ1R15MTK7) LEVOMENTHOL 100 mg LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 400 mg Inactive Ingredients Ingredient Name Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) MINERAL OIL (UNII: T5L8T28FGP) POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W) WATER (UNII: 059QF0KO0R) KAOLIN (UNII: 24H4NWX5CO) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) POLYSORBATE 80 (UNII: 6OZP39ZG8H) GLYCERIN (UNII: PDC6A3C0OX) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) EDETATE DISODIUM (UNII: 7FLD91C86K) TARTARIC ACID (UNII: W4888I119H) POVIDONE K90 (UNII: RDH86HJV5Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:83391-008-01 1 in 1 BAG; Type 0: Not a Combination Product 03/11/2025 2 NDC:83391-008-02 10 in 1 BOX; Type 0: Not a Combination Product 03/11/2025 3 NDC:83391-008-03 30 in 1 BOX; Type 0: Not a Combination Product 03/11/2025 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 03/11/2025 Labeler - SHENZHEN YUWEN E-COMMERCE CO., LTD. (544559614)