Label: XR CELLULAR MAGIC- sodium hyaluronate gel
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Contains inactivated NDC Code(s)
NDC Code(s): 70663-008-01, 70663-008-02 - Packager: MESO SYSTEM S.A.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated December 17, 2016
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- Warnings
- WARNINGS
- USES
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- QUESTIONS OR COMMENTS ?
- ACTIVE INGREDIENTS
- Inactive Ingredients
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
XR CELLULAR MAGIC
sodium hyaluronate gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70663-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM 0.1 mg in 1 mL Inactive Ingredients Ingredient Name Strength POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O) 0.2 mg in 1 mL BORAGO OFFICINALIS FLOWER (UNII: 7X23S1OW1N) 0.2 mg in 1 mL ASCORBYL PALMITATE (UNII: QN83US2B0N) 0.1 mg in 1 mL DIPROPYLENE GLYCOL (UNII: E107L85C40) 10 mg in 1 mL SODIUM MANNURONATE METHYLSILANOL (UNII: 6ZK10JO456) 5 mg in 1 mL WATER (UNII: 059QF0KO0R) 80.3 mg in 1 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg in 1 mL PEG-30 GLYCERYL LINOLEATE (UNII: UPJ8VI2ZOC) 1 mg in 1 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg in 1 mL GLYCERYL ARACHIDONATE (UNII: I4WS2B978B) 1 mg in 1 mL GLYCERYL LINOLENATE (UNII: SGB6X4G86K) 1 mg in 1 mL DEANOL (UNII: 2N6K9DRA24) 0.1 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70663-008-02 1 in 1 BOX 12/17/2016 1 NDC:70663-008-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/17/2016 Labeler - MESO SYSTEM S.A. (768263100) Registrant - MESO SYSTEM S.A. (768263100) Establishment Name Address ID/FEI Business Operations MESO SYSTEM S.A. 768263100 manufacture(70663-008)