SMOOTH GATOR HEAD-EZZ ANALGESIC- menthol cream 
Smooth Gator LLC

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SMOOTH GATOR Head-Ezz Topical Analgesic Cream

DRUG FACTS

Active Ingredients:

Menthol 3.00%

Purpose

Topical Analgesic

Indications:

For the temporary relief of minor aches and pains.

Warnings

Keep out of reach of children.

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

Directions:

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

SMOOTH GATOR HEAD-EZZ ANALGESIC 
menthol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70673-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL30 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70673-501-0060 mL in 1 BOTTLE; Type 0: Not a Combination Product06/13/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/13/2024
Labeler - Smooth Gator LLC (029819479)
Establishment
NameAddressID/FEIBusiness Operations
Pure Source, LLC080354456manufacture(70673-501)

Revised: 6/2024
Document Id: 1a820f59-518c-a238-e063-6294a90a1d1f
Set id: 02e18e5d-6fb0-4ebf-bdd6-dcc7edbb31bd
Version: 1
Effective Time: 20240610
 
Smooth Gator LLC