Painkoolers Topical Analgesic Patch
FDA Label NDC 70118-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ga Health And Beauty (foshan) Co., Ltd for the product Painkoolers Topical Analgesic Patch (NDC 70118-001). 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 active ingredients:, otc - purpose, uses:, warnings:, keep out of reach of children., directions:, other ingredients:, package label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Menthol 5.00%
Capsaicin 0.05%

Otc - Purpose

Analgesic/Counterirritant
External Analgesic

Uses:

For the temporary relief of minor aches and pains of the muscles and joints associated with simple backache, arthritis, sprains, bruises and strains.

Warnings:

For external use only.

  • Use only as directed. Avoid contact with eyes and mucous membranes.
  • Do not cover with bandage.
  • Do not use on wounds or damaged skin.
  • Do not use if you are allergic to Menthol.
  • Stop use and ask a doctor if conditions worsen, symptoms persist for more than 7 days or clear up and occur again within a few days.
  • Or Rash, itching or excessive skin irritation occurs.

Keep Out Of Reach Of Children.

Consult Physician for children under 12.

Directions:

  • Adults and children 12 years and over apply to affected area.
  • Change patch 1 to 2 times daily.
  • Children under 12 years, consult physician before use.

    • How to apply:

    Clean and dry affected area
    Cut open pouch and remove patch
    Remove protective film and apply directly to area of pain
    Apply to affected area not more than 3 times daily
    Wash hands with soap after applying patch
    Reseal pouch containing unused patches

Other Ingredients:

Water, Glycerine, Sodium Polyacrylate, Polyscorbate 80, Aloe Barbadesis Leaf (Aloe Vera Gel) Juice, EDTA Disodium salt, Diaxolidinyl Urea, Methylparaben, Iodoproynyl Butylcarbamate, Propylparaben.

Package Label

Painkoolers (Painkoolers)

Painkoolers (Painkoolers)

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