Label: ALIVIO- lidocaine patch
- NDC Code(s): 82598-101-01, 82598-101-03, 82598-101-20
- Packager: Amerise Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 27, 2024
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- Official Label (Printer Friendly)
- Active Ingredients
- Use
- PURPOSE
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Warnings
For external use only.
Do not use
- more than 1 patch on your body at a time or on cut, irritated or swollen skin
- on puncture wounds
- for more than one week without consulting a doctor
When using this product
- use only as directed. Read and follow all directions and warning on this carton
- rare cases of serious burns have been reported with products of this type
- do not apply to wonds or damaged, broken or irritated skin
- do not allow contact with the eyes and mucous membranes
- do not bandage tightly or apply local heat (such as heating pads) to the area of use
- do not use at the same time as other topical analgesics
- dispose of used patch in manner that always keep 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
- a transient buring sensation may occur upon applicaiton but generally disappears in several day
- if a severe buring sensation occurs, discontinue use immediately
Stop use and ask a doctor if
- condition worsens
- redness is present
- irritation develops
- sypmtoms persist for more than 7 days or clear up and occur again within a few days
- you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.
If pregnant or breast-feeding, ask a health professional before use.
- KEEP OUT OF REACH OF CHILDREN
- Directions
- Inactive Ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALIVIO
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:82598-101 Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g Inactive Ingredients Ingredient Name Strength ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) ALUMINUM SILICATE (UNII: T1FAD4SS2M) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) MINERAL OIL (UNII: T5L8T28FGP) ROSIN (UNII: 88S87KL877) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMER (UNII: K7S96QM8DV) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) ISOPRENE (UNII: 0A62964IBU) ISOBUTYLENE (UNII: QA2LMR467H) POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:82598-101-20 20 in 1 CARTON 06/17/2022 1 NDC:82598-101-01 1 in 1 PATCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 2 NDC:82598-101-03 3 in 1 CARTON; Type 0: Not a Combination Product 06/16/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 06/16/2022 Labeler - Amerise Pharmaceuticals LLC (089951382)