Label: SCALPANUMB- lidocaine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 54723-001-01 - Packager: Sambria Pharmaceuticals, LLC
- Category: HUMAN OTC DRUG LABEL
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated September 17, 2021
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- Drug Facts
- Active ingredient
- Purpose
- Uses
- warnings
- Directions
- Keep out of reach of children
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Inactive ingredients
Aqua (Deionized Water), Arnica Montana Floweri Extract, C13-14 Isoparaffin, Chondroitin Sulfate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Isopropyl Palmitate, Laureth-7, Melaleuca Alternifolia (Tea Tree) Oil, Methylsulfonylmenthane (MSM), Phenoxyethanol, Polyacrylamide, Propylene Glycol, Stearic Acid, Triethanolamine.
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INGREDIENTS AND APPEARANCE
SCALPANUMB
lidocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54723-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE 4 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) SODIUM CHONDROITIN SULFATE (PORCINE; 5500 MW) (UNII: H5BJH23Z9A) EMU OIL (UNII: 344821WD61) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) LAURETH-7 (UNII: Z95S6G8201) MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K) DIMETHYL SULFONE (UNII: 9H4PO4Z4FT) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54723-001-01 59.14 mL in 1 TUBE; Type 0: Not a Combination Product 09/16/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 09/16/2021 Labeler - Sambria Pharmaceuticals, LLC (078676259) Establishment Name Address ID/FEI Business Operations Speciality Pharma Manufacturing, LLC 013957125 manufacture(54723-001)