Lidocaine Pain Relief Patch

Lidocaine Pain Relief Patch
SPL v2
SPL
SPL Set ID 3fe1a160-6508-62ea-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2016-09-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol, Unspecified Form (1 g) Lidocaine (4 g)
Inactive Ingredients
Polyacrylic Acid (250000 Mw) Dihydroxyaluminum Aminoacetate Glycerin Kaolin Methylparaben Polysorbate 80 Propylparaben Water Povidone, Unspecified Sodium Polyacrylate (2500000 Mw) Propylene Glycol Tartaric Acid Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Shape: rectangle
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-09-01

Description

Lidocaine 4% Menthol 1%

Purpose

Topical anesthetic Topical anesthetic

Dosage and Administration

Lidocaine Pain Relief Patch contains 4% Lidocaine and 1% Menthol.


Medication Information

Purpose

Topical anesthetic Topical anesthetic

Dosage and Administration

Lidocaine Pain Relief Patch contains 4% Lidocaine and 1% Menthol.

Description

Lidocaine 4% Menthol 1%

Uses:

For the temporary relief of pain.

Purpose:

Topical anesthetic

Topical anesthetic

Warnings

For external use only

Avoid contact with eyes.

Directions

Adults and children over 12 years of age:

  • clean and dry affected area
  • strip off the clear protective film and place adhesive patch over affected area
  • leave in place for up to 8 hours
  • wash hands thoroughly after applying or removing patch.

Children under 12 years: ask a doctor before use.

Do Not Use
  • if you are allergic to any active and inactive ingredients listed in this patch
  • if pouch is damaged or opened
  • on raw surfaces or blistered areas, open wounds, or on damaged, cut, irriated or sensitive skin
  • for more than one week without consulting a doctor.
Other Information

Store below 25°C (77°F). Avoid direct sunilght.

Active Ingredients

Lidocaine 4%

Menthol 1%

Inactive Ingredients:

dihydroxyaluminum aminoacetate, glycerin,kaolin,methylparaben,polyacrylic acid,polysorbate 80,propylene glycol,propylparaben, povidone,sodium polyacrylate, tartaric acid,tatanium dioxide,water.

Questions Or Comments?

Please call 1-800-290-6816 (Mon-Fri 9AM-5PM CST)

When Using This Product
  • use only as directed. Read and follow all directions and warnings on this package
  • do not allow contact with eyes or 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
  • do not reuse patch
  • dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Lidocaine Pain Relief Patch

Stop Use and Ask A Doctor If
  • conditions worsens
  • rash, itching or skin irritation develops
  • symptoms persist for more than 7 days or clear up and occurs 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

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses:

For the temporary relief of pain.

Purpose:

Topical anesthetic

Topical anesthetic

Warnings

For external use only

Avoid contact with eyes.

Directions

Adults and children over 12 years of age:

  • clean and dry affected area
  • strip off the clear protective film and place adhesive patch over affected area
  • leave in place for up to 8 hours
  • wash hands thoroughly after applying or removing patch.

Children under 12 years: ask a doctor before use.

Do Not Use (Do not use)
  • if you are allergic to any active and inactive ingredients listed in this patch
  • if pouch is damaged or opened
  • on raw surfaces or blistered areas, open wounds, or on damaged, cut, irriated or sensitive skin
  • for more than one week without consulting a doctor.
Other Information

Store below 25°C (77°F). Avoid direct sunilght.

Active Ingredients

Lidocaine 4%

Menthol 1%

Inactive Ingredients:

dihydroxyaluminum aminoacetate, glycerin,kaolin,methylparaben,polyacrylic acid,polysorbate 80,propylene glycol,propylparaben, povidone,sodium polyacrylate, tartaric acid,tatanium dioxide,water.

Questions Or Comments? (Questions or Comments?)

Please call 1-800-290-6816 (Mon-Fri 9AM-5PM CST)

When Using This Product (When using this product)
  • use only as directed. Read and follow all directions and warnings on this package
  • do not allow contact with eyes or 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
  • do not reuse patch
  • dispose of used patch in manner that always keeps product away from children or pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.
Dosage and Administration

Lidocaine Pain Relief Patch contains 4% Lidocaine and 1% Menthol.

Lidocaine Pain Relief Patch

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • conditions worsens
  • rash, itching or skin irritation develops
  • symptoms persist for more than 7 days or clear up and occurs 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 (If pregnant or breast feeding)

ask a health professional before use.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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