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AlloPAX: Package Insert / Prescribing Info

Package insert / product label
Generic name: levocetirizine dihydrochloride, loratadine
Dosage form: topical application

On This Page

Each Allo•PAX provides 3 grams of Levocetirizine dihydrochloride, 3 grams Loratadine USP, and 54 grams of Base. The resulting mixture is intended for transdermal use.

For Prescription Use Only

Distributed by:

PharmaGenetico LLC

San Antonio, TX 78257

AlloPAX Insert

AlloPAX Labels

ALLOPAX
levocetirizine dihydrochloride 5%, loratadine 5% kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69817-0201
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69817-0201-11 in 1 BOX; Type 0: Not a Combination Product06/30/201511/23/2016
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 3 g in 3
Part 21 BOTTLE, PLASTIC 3 g in 3
Part 31 JAR 54 g in 54
Part 1 of 3
LORATADINE
loratadine powder, for suspension
Product Information
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LORATADINE (UNII: 7AJO3BO7QN) (LORATADINE - UNII:7AJO3BO7QN) LORATADINE3 g in 3 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other
Part 2 of 3
LEVOCETIRIZINE DIHYDROCHLORIDE
levocetirizine dihydrochloride powder, for suspension
Product Information
Route of AdministrationTRANSDERMAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O) LEVOCETIRIZINE DIHYDROCHLORIDE3 g in 3 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
13 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other
Part 3 of 3
CREAM BASE
cream base cream
Product Information
Route of AdministrationTRANSDERMAL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
154 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/30/2015
Labeler - PharmaGenetico LLC (079713987)
Establishment
NameAddressID/FEIBusiness Operations
Mission Pharmacal Company927726893manufacture(69817-0201)

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