SMOOTH GATOR HEAD-EZZ ANALGESIC- menthol cream

SMOOTH GATOR Head-Ezz Analgesic by

Drug Labeling and Warnings

SMOOTH GATOR Head-Ezz Analgesic by is a Otc medication manufactured, distributed, or labeled by Smooth Gator LLC, Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

SMOOTH GATOR HEAD-EZZ ANALGESIC 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70673-501
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LICORICE (UNII: 61ZBX54883)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
PEPPERMINT OIL (UNII: AV092KU4JH)
METHYLPARABEN (UNII: A2I8C7HI9T)
METHYL SALICYLATE (UNII: LAV5U5022Y)
MINERAL OIL (UNII: T5L8T28FGP)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ROSEMARY (UNII: IJ67X351P9)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70673-501-00	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/13/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	06/13/2024

Labeler - Smooth Gator LLC (029819479)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(70673-501)