AlloPAX: Package Insert / Prescribing Information - Drugs.com

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# AlloPAX

Package insert / prescribing information
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. Read further information about unapproved drugs.

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

Medical Disclaimer