Label: ALLOPAX- levocetirizine dihydrochloride 5%, loratadine 5% kit
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Contains inactivated NDC Code(s)
NDC Code(s): 69817-0201-1 - Packager: PharmaGenetico LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated July 25, 2017
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- DESCRIPTION
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- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALLOPAX
levocetirizine dihydrochloride 5%, loratadine 5% kitProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69817-0201 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69817-0201-1 1 in 1 BOX; Type 0: Not a Combination Product 06/30/2015 11/23/2016 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE, PLASTIC 3 g in 3 Part 2 1 BOTTLE, PLASTIC 3 g in 3 Part 3 1 JAR 54 g in 54 Part 1 of 3 LORATADINE
loratadine powder, for suspensionProduct Information Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE 3 g in 3 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 3 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other Part 2 of 3 LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride powder, for suspensionProduct Information Route of Administration TRANSDERMAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O) LEVOCETIRIZINE DIHYDROCHLORIDE 3 g in 3 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 3 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other Part 3 of 3 CREAM BASE
cream base creamProduct Information Route of Administration TRANSDERMAL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) WHEAT GERM OIL (UNII: 14C97E680P) CETYL ALCOHOL (UNII: 936JST6JCN) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) XANTHAN GUM (UNII: TTV12P4NEE) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) EDETATE DISODIUM (UNII: 7FLD91C86K) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) PHENOXYETHANOL (UNII: HIE492ZZ3T) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 54 g in 1 JAR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 06/30/2015 Labeler - PharmaGenetico LLC (079713987) Establishment Name Address ID/FEI Business Operations Mission Pharmacal Company 927726893 manufacture(69817-0201)
