Label: SMOOTH GATOR HEAD-EZZ ANALGESIC- menthol cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 10, 2024

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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