Smooth Gator Foot And Leg Rub Cream
FDA Label NDC 70673-297

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Smooth Gator Llc for the product Smooth Gator Foot And Leg Rub (NDC 70673-297). 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:, indications:, warnings:, keep out of reach of children., directions:, additional information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients:

Camphor 4.00%

Menthol 1.25%

Purpose:

Topical Analgesic

Indications:

For the temporary relief of minor aches and pains of the muscles and joints.

Warnings:

  • For external use only.
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.

Keep Out Of Reach Of Children.

  • If swallowed, consult physician.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

Directions:

  • Adults and children two-years of age or older:

    • Apply to affected area not more than three to four times daily.

    • Children under two-year of age: consult a physician

Additional Information:

Store at room temperature.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Eucalyptus Globulus Oil, Glyceryl Stearate, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Methyl Paraben, Methyl Salicylate, PEG-100 Stearate, Polyacrylamide, Polysorbate-20, Propyl Paraben, Propylene Glycol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Retinyl Palmitate (Vitamin A), Rosmarinus Officinalis (Rosemary) Extract, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethanolamine.

Package Labeling:

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