Perform Cool And Soothing Pain Relieving Gel
FDA Label NDC 59316-111

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Reckitt Benckiser Llc for the product Perform Cool And Soothing Pain Relieving (NDC 59316-111). 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, uses:, warnings:, flammable:, ask a doctor before using if you:, when using this product:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Menthol 3.5%

Purpose

Cooling Pain Relief

Uses:

Soothing temporary relief from minor aches and pains associated with sore muscles, strains, joint discomfort and arthritis.

Warnings:

​For external use only.

Flammable:

Keep away from excessive heat and open flame.

Ask A Doctor Before Using If You:

Have sensitive skin, are pregnant or are breastfeeding.

When Using This Product:

  • Avoid contact with eyes or mucous membranes
  • Do not apply to wounds, damaged or irritated skin, or if excessive irritation develops
  • Do not bandage or use with a heating pad or device, ointments, creams, sprays, liniments
  • Wash hands with cool water after using

Stop Use And Ask Doctor If:

Condition worsens, symptoms persist more than 7 days, or clear up and reoccur.

Keep Out Of Reach Of Children:

If ingested, get medical help.  Contact Poison Control Center immediately.

Directions:

  • Adults/Children 2 years or older:  Massage onto affected area up to 4 times daily.
  • Children under 2 years of age: Consult a physician.

Other Information:

Store in a cool, dry place with lid close tightly.

Inactive Ingredients:

Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Blue 1, Camelia Sinensis Leaf Extract, Carbomer, Citrus Aurantifolia (lime) Oil, Citrus Auratium Dulcis (Orange) Peel Oil, Eucalyptus Globulus Leaf Oil, Glycerin, Hypericum Perforatum Oil, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Lavandula Hybrida Oil, Mentha Piperita (Peppermint) Oil, Myristica Fragrans (Nutmeg) Kerneol Oil, Pinus Sytvestris Leaf Oil, Polysorbate 20, Silica, Thymus Vulgaris (Thyme) Flower/Leaf Oil, Triethanolamine, Water.

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