Smooth Gator Head-ezz Analgesic Cream
FDA Label NDC 70673-501

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 Head-ezz Analgesic (NDC 70673-501). 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:

Menthol 3.00%

Purpose

Topical Analgesic

Indications:

For the temporary relief of minor aches and pains.

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-years of age: consult a physician

Additional Information:

Store at room temperature

Inactive Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camphor, Diazolidinyl Urea, Eucalyptus Globulus Oil, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Melaleuca Alternifolia (Tea Tree) Oil, Mentha Piperita (Peppermint) Oil, Methyl Paraben, Methyl Salicylate, Mineral Oil, Parfum (Fragrance), PEG-100 Stearate, Polysorbate-20, Propyl Paraben, Propylene Glycol, Retinyl Palmitate (Vitamin E), Rosmarinus Officinalis (Rosemary) Extract, Tocopheryl Acetate (Vitamine E), Triethanolamine.

Package Labelling:

Bottle (Bottle)

Bottle (Bottle)

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