Topcare Pain Relief Patch Lidocaine Plus Menthol

Topcare Pain Relief Patch Lidocaine Plus Menthol
SPL v4
SPL
SPL Set ID d4c89c4f-d69a-7786-e053-2995a90a71e7
Route
TOPICAL
Published
Effective Date 2022-01-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-01

Description

Lidocaine 4% Menthol 1%

Purpose

Topical anesthetic Topical analgesic


Medication Information

Purpose

Topical anesthetic Topical analgesic

Description

Lidocaine 4% Menthol 1%

Use

for the temporary relief of pain

Purposes

Topical anesthetic



Topical analgesic

Warnings

For external use only

Directions

adults and children 12 years of age and over:

  • clean and dry affected area
  • carefully remove backing from patch starting at a corner.
  • Appli sticky side of patch to affected area.
  • Use one patch for up to 12 hours
  • Dispatch patch after a single use.
  • children under 12 years of age: consult a physician
Do Not Use
  • more than 1 patch on your body at a time
  • On cut, irritated, or swollen skin
  • on puncture wounds
  • For more than one week without consulting a doctor
  • If you are allergic to any active or inactive ingredients
  • if pouch is damaged or opened
Active Ingredients

Lidocaine 4%



Menthol 1%

Inactive Ingredients

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water.

When Using This Product
  • use only as directed
  • Read and follow all directions and warnings on this carton
  • Do not allow contact with the eyes
  • Do not use at the same time as other topical analgesics
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • dispose of used patch in manner that always keeps 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.
Stop Use and Ask A Doctor If
  • condition worsens
  • Redness is present
  • Irritation develops
  • Symptoms 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.

Package/label Principal Display Panel

Keep Out of Reach of Children and Pets.

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.


Structured Label Content

Use

for the temporary relief of pain

Purposes

Topical anesthetic



Topical analgesic

Warnings

For external use only

Directions

adults and children 12 years of age and over:

  • clean and dry affected area
  • carefully remove backing from patch starting at a corner.
  • Appli sticky side of patch to affected area.
  • Use one patch for up to 12 hours
  • Dispatch patch after a single use.
  • children under 12 years of age: consult a physician
Do Not Use (Do not use)
  • more than 1 patch on your body at a time
  • On cut, irritated, or swollen skin
  • on puncture wounds
  • For more than one week without consulting a doctor
  • If you are allergic to any active or inactive ingredients
  • if pouch is damaged or opened
Active Ingredients (Active ingredients)

Lidocaine 4%



Menthol 1%

Inactive Ingredients (Inactive ingredients)

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water.

When Using This Product (When using this product)
  • use only as directed
  • Read and follow all directions and warnings on this carton
  • Do not allow contact with the eyes
  • Do not use at the same time as other topical analgesics
  • Do not bandage tightly or apply local heat (such as heating pads) to the area of use
  • Do not microwave
  • dispose of used patch in manner that always keeps 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.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens
  • Redness is present
  • Irritation develops
  • Symptoms 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, (If pregnant or breast-feeding,)

ask a health professional before use.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.


Advanced Ingredient Data


Raw Label Data

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