83391-006 Lidocain Pain Relief Patch

83391-006 Lidocain Pain Relief Patch
SPL v3
SPL
SPL Set ID 8be203e3-9031-4247-bf7a-757a36fd7707
Route
TOPICAL
Published
Effective Date 2024-10-30
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) Kaolin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-30

Description

Drug Facts

Purpose

Topical Analgestic


Medication Information

Purpose

Topical Analgestic

Description

Drug Facts

Use

Temporarily relieves minor pain

Section 50565-1

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children and pets.If swallowed, get medical help or contact a Poison Control Center right away.

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%

Warnings

For external use only

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

Do not use in large quantities, particularly over raw surfaces or blistered areas

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
  • Apply to affected area not more than 3-4 times daily
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
  • 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

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

Stop Use and Ask 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
Auvon Lidocaine Pain Relief Patch

Drug Facts


Structured Label Content

Use

Temporarily relieves minor pain

Section 50565-1 (50565-1)

If pregnant or breast-feeding,ask a health professional before use.

Keep out of reach of children and pets.If swallowed, get medical help or contact a Poison Control Center right away.

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%

Warnings

For external use only

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

Do not use in large quantities, particularly over raw surfaces or blistered areas

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
  • Apply to affected area not more than 3-4 times daily
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
  • 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)

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

Stop Use and Ask A Doctor (Stop use and ask 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
Auvon Lidocaine Pain Relief Patch (AUVON Lidocaine Pain Relief Patch)

Drug Facts


Advanced Ingredient Data


Raw Label Data

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