Careland Lidocaine Plus Menthol Pain Relieving Patch
FDA Label NDC 75568-016

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Planet (anhui) Pharmaceutical Co. Ltd. for the product Careland Lidocaine Plus Menthol Pain Relieving (NDC 75568-016). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, use, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Drug Facts

Active Ingredients

Lidocaine 4.0%

Menthol 1.0%

Purpose

Topical Anesthetic

Use

for temperorary relief of pain

Warnings

For external use only

Do Not Use

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product

When Using This Product

  • use only as directed
  • do not bandage tightly
  • avoid contact with the eyes, mucous membranes or rashes

Stop Use And Ask A Doctor If

  • symptoms persist for more than 7 days
  • conditions worsen
  • symptoms clear up and occur again within few days
  • localized skin reactions, such as rash, itching, redness, pain, swelling and blistering develop

If Pregnant Or Breasatfeeding,

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.

Directions

Adults and Children 12 years of age and over:

  • clean and dry affected area
  • remove film from patch and apply to skin
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • CHildren under 12 years of age: cnsult a doctor

Other Information

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

Inactive Ingredients

Azone, Castor oil, CMC-Na, Dihydroxyaluminum Aminoacetate, Glycerol, Isopropyl Myristate, Kaolin, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Sorbitol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

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