83391-005 Lidocain Pain Relief Patch

83391-005 Lidocain Pain Relief Patch
SPL v2
SPL
SPL Set ID 293c9f33-d2f9-4dd5-86d5-785724462347
Route
TOPICAL
Published
Effective Date 2024-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Glycerin Water Sodium Polyacrylate (8000 Mw) Methylparaben Propylparaben Dihydroxyaluminum Aminoacetate Tartaric Acid Povidone, Unspecified Polysorbate 80 Titanium Dioxide Propylene Glycol Polyacrylic Acid (8000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-21

Description

Drug Facts

Purpose

Topical Analgestic


Medication Information

Purpose

Topical Analgestic

Description

Drug Facts

Use

Temporarily relieves minor pain

Section 51945-4

Storage
  • Avoid storing patches in direct sunlight
  • Protect patches from excessive moisture
  • Please store it at room temperature 20-25 C (68-77F)
Active I

Lidocaine HCl 4%

Keep Out

If ingested, get medical help right away.

Warnings

Please read all directions and warnings as follows and use only as directed. For external use only

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.
  • Wash hands with cool water after use
  • Cutting first if used on joints
  • Do not repeatedly use or reapply the patch as far as possible
Do Not Use
  • Alone if you are under 12 years of age, please consult a doctor
  • If you are allergic to the listed ingredients
  • If the package arrives damaged or opened.
  • If you are pregnent or breast feeding
  • On cuts, puncture wounds, and damaged, broken, swollen, or irritated skin
  • On eyes and mucous membranes
  • More than one patch on your body at a time or with other topical analgesics at the same time
  • Tightly wrapped or localized heat (e.g. heating pads) in the area of use.
Inactive Ingredients

Glycerin, Sodium polyacrylate, Water, Methylparaben, Propylparaben, Dihydroxyaluminum aminoacetate, Tartaric acid, PVP, Polysorbate 80, Kaolin, Titanium Dioxide, Propylene glycol, Polyacrylic acid

Auvon Lidocaine Pain Relief Patch

Drug Facts

Discontinue Use and Consult A Doctor
  • if symptoms persist for more than 7 days or clear up and occur again within a few days
  • If you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, or blistering

Structured Label Content

Use

Temporarily relieves minor pain

Section 51945-4 (51945-4)

Purpose

Topical Analgestic

Storage
  • Avoid storing patches in direct sunlight
  • Protect patches from excessive moisture
  • Please store it at room temperature 20-25 C (68-77F)
Active I (Active i)

Lidocaine HCl 4%

Keep Out (Keep out)

If ingested, get medical help right away.

Warnings

Please read all directions and warnings as follows and use only as directed. For external use only

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.
  • Wash hands with cool water after use
  • Cutting first if used on joints
  • Do not repeatedly use or reapply the patch as far as possible
Do Not Use (Do not use)
  • Alone if you are under 12 years of age, please consult a doctor
  • If you are allergic to the listed ingredients
  • If the package arrives damaged or opened.
  • If you are pregnent or breast feeding
  • On cuts, puncture wounds, and damaged, broken, swollen, or irritated skin
  • On eyes and mucous membranes
  • More than one patch on your body at a time or with other topical analgesics at the same time
  • Tightly wrapped or localized heat (e.g. heating pads) in the area of use.
Inactive Ingredients (Inactive ingredients)

Glycerin, Sodium polyacrylate, Water, Methylparaben, Propylparaben, Dihydroxyaluminum aminoacetate, Tartaric acid, PVP, Polysorbate 80, Kaolin, Titanium Dioxide, Propylene glycol, Polyacrylic acid

Auvon Lidocaine Pain Relief Patch (AUVON Lidocaine Pain Relief Patch)

Drug Facts

Discontinue Use and Consult A Doctor (Discontinue use and consult a doctor)
  • if symptoms persist for more than 7 days or clear up and occur again within a few days
  • If you experience any signs of deterioration or skin injury, such as redness, irritation, swelling, or blistering

Advanced Ingredient Data


Raw Label Data

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