Label: ECLIPSE TOPICAL ANALGESIC FA- benzocaine cream
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Contains inactivated NDC Code(s)
NDC Code(s): 54723-668-08 - Packager: Sambria Pharmaceuticals, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 August 6, 2018
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- Active Ingredients
- Purpose
- Uses
- Warnings
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
- Directions
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Inactive Ingredients
Aqua (Deionized Water), Arnica Montana Flower Extract, C13-14 Isoparaffin, Caprylic/Capric Triglyceride, Cetearetj-25, Chondroitin Sulfate, Diethylhexyl Sodium Sulfosuccinate, Emu Oil, Ethoxydiglycol, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Isopropyl Palmitate, Laureth-7, Melaleuca alternifolia (Tea Tree) Leaf Oil, Methylfulfonylmenthane (MSM), Phenoxyethanol, Polyacrylamide, Polysorbate-20, Safflower Oil, Stearic Acid, Triethanolamine
- Other Information
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INGREDIENTS AND APPEARANCE
ECLIPSE TOPICAL ANALGESIC FA
benzocaine creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54723-668 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE 20 mg in 100 mg Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CETEARETH-25 (UNII: 8FA93U5T67) CHONDROITIN SULFATE SODIUM (BOVINE) (UNII: 8QTV3DTT8W) DOCUSATE SODIUM (UNII: F05Q2T2JA0) EMU OIL (UNII: 344821WD61) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) GLUCOSAMINE SULFATE (UNII: 1FW7WLR731) GLYCERIN (UNII: PDC6A3C0OX) 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) POLYSORBATE 20 (UNII: 7T1F30V5YH) SAFFLOWER OIL (UNII: 65UEH262IS) STEARIC ACID (UNII: 4ELV7Z65AP) TROLAMINE (UNII: 9O3K93S3TK) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54723-668-08 1500 mg in 1 PACKET; Type 0: Not a Combination Product 02/01/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/01/2016 Labeler - Sambria Pharmaceuticals, Inc. (078676259) Establishment Name Address ID/FEI Business Operations A.I.G. Technologies, Inc. 171837367 manufacture(54723-668) Establishment Name Address ID/FEI Business Operations JP Packaging LLC 151369456 repack(54723-668)