Theracare Maximum Strength Pain Relief Patch

Theracare Maximum Strength Pain Relief Patch
SPL v4
SPL
SPL Set ID dfaf8a77-2276-4791-e053-2a95a90a3288
Route
TOPICAL
Published
Effective Date 2022-05-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 mg)
Inactive Ingredients
Benzyl Alcohol Dihydroxyaluminum Aminoacetate Anhydrous Polyacrylic Acid (250000 Mw) Glycerin Povidone, Unspecified Ethylhexylglycerin Polysorbate 80 Propylene Glycol Phenoxyethanol Tartaric Acid Titanium Dioxide Kaolin Water Sodium Polyacrylate (8000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-01

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Use

temporary relieves minor pain

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 the corner
  • Apply sticky side of patch to affected area.
  • Use one patch for up to 12 hours.
  • Discard patch after single use
  • children under 12 years or 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 Ingredient

Lidocaine 4%

Other Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture

Inactive Ingredients

aluminum glycinate, benzyl alcohol, ethylhexylglycerin, glycerin, kaolin, phenoxyethanol, polyacrylic acid, polysorbate 80, propylene glycol, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Principal Display Panel

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 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.
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.

Keep Out of Reach of Children and Pets

If swallowed, get medical help or contact a Poison Control Center 1-800-222-1222 right away.


Structured Label Content

Use

temporary relieves minor pain

Purpose

Topical anesthetic

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 the corner
  • Apply sticky side of patch to affected area.
  • Use one patch for up to 12 hours.
  • Discard patch after single use
  • children under 12 years or 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 Ingredient (Active ingredient)

Lidocaine 4%

Other Information (Other information)

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture

Inactive Ingredients (Inactive ingredients)

aluminum glycinate, benzyl alcohol, ethylhexylglycerin, glycerin, kaolin, phenoxyethanol, polyacrylic acid, polysorbate 80, propylene glycol, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Principal Display Panel (Principal display panel)

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 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.
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.

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 1-800-222-1222 right away.


Advanced Ingredient Data


Raw Label Data

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