Label: SMOOTH GATOR HEAD-EZZ ANALGESIC- menthol cream
- NDC Code(s): 70673-501-00
- Packager: Smooth Gator LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 10, 2024
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- DRUG FACTS
- Active Ingredients:
- Indications:
- Warnings
- Directions:
- Additional Information:
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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:
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INGREDIENTS AND APPEARANCE
SMOOTH GATOR HEAD-EZZ ANALGESIC
menthol creamProduct 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)