Label: LIDOCAINE patch
- NDC Code(s): 50488-2004-1
- Packager: Alexso, Inc
- 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 October 27, 2022
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only.
Read all warnings and directions before use.
Do not use
• More than one patch at a time
• On wounds or damaged skin
• With a heating pad
• If you are allergic to any ingredients of this product
Allergy Alert: if you are allergic to any inactive ingredient of this product, contact a doctor before use.
When using this product
• Use only as directed.
• Avoid contact with eyes, mucous membranes, or rashes
• Do not tightly wrap or bandage the treated area
Stop use and ask a physician:
• If pregnant or breast feeding
• If localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling, and blistering
• If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.
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Directions
Adults and children 12 years of age and older:
Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave patch on for more than 8 hours at a time.
- 1.
- Clean and dry the affected area.
- 2.
- Open pouch and remove one patch.
- 3.
- Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.
- 4.
- Wash hands with soap and water after handling the patches.
- 5.
- Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.
- 6.
- Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.
Children under 12 years: Ask a physician
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LIDOCAINE
lidocaine patchProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:50488-2004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POLYSORBATE 80 (UNII: 6OZP39ZG8H) TARTARIC ACID (UNII: W4888I119H) DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6) METHYLPARABEN (UNII: A2I8C7HI9T) PEPPERMINT OIL (UNII: AV092KU4JH) SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:50488-2004-1 10 in 1 CARTON 01/15/2020 1 100 g in 1 PATCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part348 01/15/2020 Labeler - Alexso, Inc (963338061)
