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AlloPAX

Generic name: levocetirizine dihydrochloride, loratadine
Dosage form: topical application

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.

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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
levocetirizine dihydrochloride 5%, loratadine 5% kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69817-0201
Packaging
# Item Code Package Description
1 NDC:69817-0201-1 1 KIT in 1 BOX
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 suspension
Product Information
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LORATADINE (LORATADINE) LORATADINE 3 g in 3 g
Packaging
# Item Code Package Description
1 3 g in 1 BOTTLE, PLASTIC
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 suspension
Product Information
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE) LEVOCETIRIZINE DIHYDROCHLORIDE 3 g in 3 g
Packaging
# Item Code Package Description
1 3 g in 1 BOTTLE, PLASTIC
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 cream
Product Information
Route of Administration TRANSDERMAL DEA Schedule
Inactive Ingredients
Ingredient Name Strength
WATER
ISOPROPYL MYRISTATE
LECITHIN, SOYBEAN
CETOSTEARYL ALCOHOL
WHEAT GERM OIL
CETYL ALCOHOL
STEARYL ALCOHOL
POLYOXYL 20 CETOSTEARYL ETHER
GLYCERIN
DIMETHICONE
C13-14 ISOPARAFFIN
LAURETH-7
XANTHAN GUM
MAGNESIUM ALUMINUM SILICATE
EDETATE DISODIUM
BUTYLATED HYDROXYTOLUENE
PHENOXYETHANOL
METHYLISOTHIAZOLINONE
METHYLCHLOROISOTHIAZOLINONE
POLYACRYLAMIDE (10000 MW)
MEDIUM-CHAIN TRIGLYCERIDES
Packaging
# Item Code Package Description
1 54 g in 1 JAR
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 Operations
Mission Pharmacal Company 927726893 manufacture(69817-0201)
PharmaGenetico LLC