Painkoolers Topical Analgesic
FDA Label NDC 70118-002

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 (NDC 70118-002). 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:, uses:, warnings:, do not use, keep out of reach of children, • do not use, • stop use, directions:, 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%

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 muccous membranes.

• Do not cover ​with bandage

Do Not Use

on wounds or damaged skin • ​ Do not use ​in combination with any other external analgesic products • Avoid contact with eyes and maccous membranes •  ​Do not use ​in combination with any external heat source. • ​ Do not use ​on irritated or broken skin, or use in combination with any bandage, wrap, stocking or similar device or garment

Keep Out Of Reach Of Children

• Consult physician for children under 12

• Do Not Use

if you are allergic or amenthol

• Stop Use

and ask a doctor id 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.

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 protected 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

Inactive Ingredients:

Purified Water,Glycerin,Polyvinyl Alcohol,Sodium Polyacrylate,Propylene Glycol,Polysorbate 80,Sorbitan Stearate,Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Aanica Montana Extract, Rosemary Oil,Tartaric Acid,Dihydroxyaluminum Aminoacetate,Titanium Dioxide,Kaolin,Glydant Plus Liquid.

Package Labeling:

Label (Label)

Label (Label)

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