Relief Pain Relieving Cream
FDA Label NDC 58559-002

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Corganics, Lp for the product Relief Pain Relieving Cream (NDC 58559-002). 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 ingredient, purpose, usage, warnings, keep out of reach of children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Menthol 3%

Purpose

Counterirritant

Usage

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

Warnings

For external use only. Avoid contact with the eyes. If condition worsens, or if symptons persist for more than 7 days or clear up and occur again after a few days, discontinue use of this product and consult a physician.

Do Not Use

  • on wounds or damaged skin
  • when bandaged tightly or with a heating pad
  • with other topical products

Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center immediately.

Directions

  • Adults and children 2 years old and older: apply a small amount to affected area not more than 3 to 4 times daily.
  • Gently massage until absorbed.
  • Children under 2 years of age: consult a physician.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Caprylic/Capric Triglycerides, Carbomer, Ceteareth-20, Cetearyl Alcohol, Cetyl Alcohol, Citrus Aurantium Dulcis (Sweet Orange) Oil, Cymbopogon Martini (Palmarosa) Oil, Deionized Water, Eucalyptus Globulus Leaf Oil, Glycerine, L-Arginine Monohydrochloride, Lavandula Angustifolia (Lavender) Oil, Lecithin, Mentha Piperita (Peppermint Oil), Methylsulfonylmethane, Phenoxyethanol, Potassium Hydroxide, Tocopheryl Acetate

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