Smooth Gator Head-ezz Topical Analgesic Cream

Smooth Gator Head-ezz Topical Analgesic Cream
SPL v1
SPL
SPL Set ID 02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd
Route
TOPICAL
Published
Effective Date 2024-06-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (30 mg)
Inactive Ingredients
Aloe Vera Leaf Water Diazolidinyl Urea Eucalyptus Oil Glycerin Glyceryl Monostearate Licorice Melaleuca Alternifolia Leaf Peppermint Oil Methylparaben Methyl Salicylate Mineral Oil Peg-100 Stearate Polysorbate 20 Propylparaben Propylene Glycol .alpha.-tocopherol Rosemary Trolamine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-13
Description

Menthol 3.00%

Purpose

Topical Analgesic

Medication Information

Purpose

Topical Analgesic

Description

Menthol 3.00%

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

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
Indications:

For the temporary relief of minor aches and pains.

Package Labelling:

Active Ingredients:

Menthol 3.00%

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.

Additional Information:

Store at room temperature

Keep Out of Reach of Children.
  • If swallowed, consult physician.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

Structured Label Content

Purpose

Topical Analgesic

Warnings
  • For external use only.
  • Avoid contact with eyes.
  • If symptoms persist for more than seven days, discontinue use and consult physician.
Drug Facts (DRUG FACTS)

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
Indications:

For the temporary relief of minor aches and pains.

Package Labelling:

Active Ingredients:

Menthol 3.00%

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.

Additional Information:

Store at room temperature

Keep Out of Reach of Children. (Keep out of reach of children.)
  • If swallowed, consult physician.
  • Do not apply to wounds or damaged skin.
  • Do not bandage tightly.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:09.517173 · Updated: 2026-03-14T23:03:04.544899