Careland Pain Relief Plus Patch
FDA Label NDC 75568-039

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 Pain Relief Plus (NDC 75568-039). 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.

Drug Facts

Active Ingredients

Camphor 3.1%

Menthol 6.0%

Methyl Salicylate 10.0%

Purpose

Topical analgesic

Use

For temporary relifeof pain

Warnings

For external use only

Do Not Use

  • More than one 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

When Using This Product

  • Use only as directed
  • Read all follow all directions and warnings
  • Do not allow contact with the eyes
  • do not allow contact with the eyes
  • Do not use at the same time as other topical anesthetics
  • 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 is a child or pet chews or ingests this patch.

Stop Use And Ask A Doctor If

  • Conditions wrosen
  • 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.

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

Directons

Adults and children 12 years of age and over:

  • Clean and dry affected area
  • Carefully remove backing from patch
  • Apply sticky side of patch to affected area
  • Use one patch for up to 8 hours
  • Discard patch after single use
  • Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
  • Children under 12 years of age: consult a physician.

Other Information

  • Store in clean, dry place outside of direct sunlight
  • Protect from excessive

Inactive Ingredients

  • • A-tocopherol acetate • Antioxidant 1010 • ESIS • Fumed Silica • Mineral Oil • Polyisobutylene • Terpene Resin

Package Labeling:

1 (Label)

1 (Label)

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