FDA Label for Smooth Gator 60-second Pain Relief

View Indications, Usage & Precautions

Smooth Gator 60-second Pain Relief Product Label

The following document was submitted to the FDA by the labeler of this product Smooth Gator Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts




Active Ingredients:



Camphor 3.00%

Menthol 1.25%


Purpose:



Topical Analgesic


Indications:



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


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:



Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Diazolidinyl Urea, Eucalyptus Globulus Oil, Lavandula Angustifolia (Lavender) Oil, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Methyl Paraben, Methyl Salicylate, PEG-8, PEG-100 Stearate, 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:227G




Package Labeling:454G




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