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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.

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)
Revised: 10/2015
 
PharmaGenetico LLC



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