AlloPAX

Manufacturer: PharmaGenetico LLC | Mission Pharmacal Company
Effective date: 2017-07-25
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 20:24:11

Label at a glance#

ProductAlloPAX

Active ingredientLORATADINE, LEVOCETIRIZINE DIHYDROCHLORIDE

Label structure4 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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.

SPL UNCLASSIFIED SECTION

For Prescription Use Only

Distributed by:

PharmaGenetico LLC

San Antonio, TX 78257

INSTRUCTIONS FOR USE SECTION

AlloPAX Insert

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AlloPAX Labels

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LEVOCETIRIZINE Pharmacologic Class Indexing	3	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
36cf9111-9cc4-8f59-a74c-0c1cfbd4a760	Product name	7	20190702

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69817-0201-1	2020-01-31	C162847	48780-1	9d75b9d0-32b9-f424-e053-dadaa90a57ce	AlloPAX

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69817-0201-1	AlloPAX	1 in 1 BOX	KIT	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69817-0201	ALLOPAX (LEVOCETIRIZINE DIHYDROCHLORIDE 5%, LORATADINE 5%) KIT [PHARMAGENETICO LLC]	3	Legacy NDC, 1 package rows	20170726_18438de2-cd75-50fa-e054-00144ff8d46c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69817-0201-1	GM - Gram	69817-0201	06efa93b-465d-47af-9a52-bb8b81c175d0	1	2015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
LEVOCETIRIZINE DIHYDROCHLORIDE	ACTIVE INGREDIENT	SOD6A38AGA	2
LORATADINE	ACTIVE INGREDIENT	7AJO3BO7QN	2
LEVOCETIRIZINE	ACTIVE MOIETY	6U5EA9RT2O	2
LORATADINE	ACTIVE MOIETY	7AJO3BO7QN	2
BUTYLATED HYDROXYTOLUENE	INACTIVE INGREDIENT	1P9D0Z171K	2
C13-14 ISOPARAFFIN	INACTIVE INGREDIENT	E4F12ROE70	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	2
LAURETH-7	INACTIVE INGREDIENT	Z95S6G8201	2
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	2
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	2
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	2
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	2
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	2
POLYACRYLAMIDE (10000 MW)	INACTIVE INGREDIENT	E2KR9C9V2I	2
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	2
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2
WHEAT GERM OIL	INACTIVE INGREDIENT	14C97E680P	2
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 27 matching rows.

AlloPAX
Levocetirizine dihydrochloride 5%, Loratadine 5%
Loratadine
Levocetirizine dihydrochloride
LEVOCETIRIZINE
Cream Base
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

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69817-0201	69817-0201-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LORATADINE	7AJO3BO7QN	ACTIB
LEVOCETIRIZINE DIHYDROCHLORIDE	SOD6A38AGA	ACTIB
WATER	059QF0KO0R	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
LECITHIN, SOYBEAN	1DI56QDM62	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
WHEAT GERM OIL	14C97E680P	IACT
CETYL ALCOHOL	936JST6JCN	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	IACT
GLYCERIN	PDC6A3C0OX	IACT
DIMETHICONE	92RU3N3Y1O	IACT
C13-14 ISOPARAFFIN	E4F12ROE70	IACT
LAURETH-7	Z95S6G8201	IACT
XANTHAN GUM	TTV12P4NEE	IACT
MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
METHYLISOTHIAZOLINONE	229D0E1QFA	IACT
METHYLCHLOROISOTHIAZOLINONE	DEL7T5QRPN	IACT
POLYACRYLAMIDE (10000 MW)	E2KR9C9V2I	IACT
MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 6 · 327 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / BUCCAL		34 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	990.3 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 29 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SUSPENSION / RECTAL		14480 mg	Exact identifier — unii candidate 17 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	GEL / TOPICAL	2 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SUSPENSION / ORAL	5000 mg/5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CAPSULE, DELAYED RELEASE / ORAL		59 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SUSPENSION/ DROPS / ORAL	4.15 mg/2.5ml		Exact identifier — unii candidate 17 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / RESPIRATORY (INHALATION)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION, CONCENTRATE / ORAL	0.1 mg/1ml		Exact identifier — unii candidate 32 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / VAGINAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	SHAMPOO / TOPICAL	1.25 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	POWDER / SUBLINGUAL		2 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	TABLET / ORAL		3 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	GUM, CHEWING / BUCCAL		5 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TRANSDERMAL		85 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
POLYOXYL 20 CETOSTEARYL ETHER	POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	AEROSOL, FOAM / TOPICAL		374 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
PHENOXYETHANOL	PHENOXYETHANOL	HIE492ZZ3T	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 6 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	0.02 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / OPHTHALMIC		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	OINTMENT / TOPICAL		57 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	SUSPENSION / RECTAL		452 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 32 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CAPSULE, LIQUID FILLED / ORAL	0.1 mg		Exact identifier — unii candidate 32 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CAPSULE / ORAL		5 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	GUM, CHEWING / BUCCAL		230 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	CREAM / VAGINAL	0.05 %w/w		Exact identifier — unii candidate 32 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / OPHTHALMIC		396 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
XANTHAN GUM	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENE	BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	SOLUTION / ORAL		14 mg	Exact identifier — unii candidate 32 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
MEDIUM-CHAIN TRIGLYCERIDES	MEDIUM-CHAIN TRIGLYCERIDES	C9H2L21V7U	INJECTION, EMULSION / INTRAVENOUS	1.1 %w/v		Exact identifier — unii candidate 18 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / TOPICAL		65000 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	LOTION / TOPICAL		3627 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATE	MAGNESIUM ALUMINUM SILICATE	6M3P64V0NC	CREAM / TOPICAL	3 %w/w		Exact identifier — unii candidate 17 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	EMULSION / OPHTHALMIC	0.3 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SUSPENSION / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	SOLUTION / TOPICAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
552a998c-bfa3-0288-e054-00144ff88e88			18438de2-cd75-50fa-e054-00144ff8d46c	2017-07-25		Exact identifier spl id: 552a998c-bfa3-0288-e054-00144ff88e88 spl set id: 18438de2-cd75-50fa-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.