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
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 November 22, 2022
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- 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 not final part348 06/16/2022 Labeler - Amerise Pharmaceuticals LLC (089951382)