Treatment Set TS335061 (Page 4 of 4)

CONTAINER LABELING

5 mL Rx Set Label
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10 mL Rx Set Label
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TREATMENT SET TS335061
treatment set ts335061 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0779
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMARANTHUS RETROFLEXUS POLLEN (AMARANTHUS RETROFLEXUS POLLEN) AMARANTHUS RETROFLEXUS POLLEN 0.002 g in 1 mL
SALSOLA KALI POLLEN (SALSOLA KALI POLLEN) SALSOLA KALI POLLEN 0.002 g in 1 mL
PLANTAGO LANCEOLATA POLLEN (PLANTAGO LANCEOLATA POLLEN) PLANTAGO LANCEOLATA POLLEN 0.002 g in 1 mL
CARYA ILLINOINENSIS POLLEN (CARYA ILLINOINENSIS POLLEN) CARYA ILLINOINENSIS POLLEN 0.001 g in 1 mL
CARYA ALBA POLLEN (CARYA ALBA POLLEN) CARYA ALBA POLLEN 0.001 g in 1 mL
JUNIPERUS VIRGINIANA POLLEN (JUNIPERUS VIRGINIANA POLLEN) JUNIPERUS VIRGINIANA POLLEN 0.002 g in 1 mL
ACER NEGUNDO POLLEN (ACER NEGUNDO POLLEN) ACER NEGUNDO POLLEN 0.002 g in 1 mL
FRAXINUS AMERICANA POLLEN (FRAXINUS AMERICANA POLLEN) FRAXINUS AMERICANA POLLEN 0.002 g in 1 mL
ULMUS AMERICANA POLLEN (ULMUS AMERICANA POLLEN) ULMUS AMERICANA POLLEN 0.002 g in 1 mL
QUERCUS ALBA POLLEN (QUERCUS ALBA POLLEN) QUERCUS ALBA POLLEN 0.002 g in 1 mL
POPULUS DELTOIDES POLLEN (POPULUS DELTOIDES POLLEN) POPULUS DELTOIDES POLLEN 0.002 g in 1 mL
BETULA NIGRA POLLEN (BETULA NIGRA POLLEN) BETULA NIGRA POLLEN 0.002 g in 1 mL
POA PRATENSIS POLLEN (POA PRATENSIS POLLEN) POA PRATENSIS POLLEN 4000 [BAU] in 1 mL
CYNODON DACTYLON POLLEN (CYNODON DACTYLON POLLEN) CYNODON DACTYLON POLLEN 400 [BAU] in 1 mL
SORGHUM HALEPENSE POLLEN (SORGHUM HALEPENSE POLLEN) SORGHUM HALEPENSE POLLEN 0.002 g in 1 mL
CHENOPODIUM ALBUM POLLEN (CHENOPODIUM ALBUM POLLEN) CHENOPODIUM ALBUM POLLEN 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0779-3 10 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS335100
treatment set ts335100 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0777
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DERMATOPHAGOIDES FARINAE (DERMATOPHAGOIDES FARINAE) DERMATOPHAGOIDES FARINAE 16 [AU] in 1 mL
ALTERNARIA ALTERNATA (ALTERNARIA ALTERNATA) ALTERNARIA ALTERNATA 0.002 g in 1 mL
CANIS LUPUS FAMILIARIS HAIR (CANIS LUPUS FAMILIARIS HAIR) CANIS LUPUS FAMILIARIS HAIR 0.002 g in 1 mL
PERIPLANETA AMERICANA (PERIPLANETA AMERICANA) PERIPLANETA AMERICANA 0.0004 g in 1 mL
GALLUS GALLUS FEATHER (GALLUS GALLUS FEATHER) GALLUS GALLUS FEATHER 0.000027 g in 1 mL
ANAS PLATYRHYNCHOS FEATHER (ANAS PLATYRHYNCHOS FEATHER) ANAS PLATYRHYNCHOS FEATHER 0.000027 g in 1 mL
ANSER ANSER FEATHER (ANSER ANSER FEATHER) ANSER ANSER FEATHER 0.000027 g in 1 mL
DERMATOPHAGOIDES PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) DERMATOPHAGOIDES PTERONYSSINUS 16 [AU] in 1 mL
CANDIDA ALBICANS (CANDIDA ALBICANS) CANDIDA ALBICANS 0.0004 g in 1 mL
ASPERGILLUS FUMIGATUS (ASPERGILLUS FUMIGATUS) ASPERGILLUS FUMIGATUS 0.002 g in 1 mL
FUSARIUM OXYSPORUM (FUSARIUM OXYSPORUM) FUSARIUM OXYSPORUM 0.002 g in 1 mL
COCHLIOBOLUS SATIVUS (COCHLIOBOLUS SATIVUS) COCHLIOBOLUS SATIVUS 0.002 g in 1 mL
CLADOSPORIUM CLADOSPORIOIDES (CLADOSPORIUM CLADOSPORIOIDES) CLADOSPORIUM CLADOSPORIOIDES 0.002 g in 1 mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.002 g in 1 mL
PHOMA DESTRUCTIVA (PHOMA DESTRUCTIVA) PHOMA DESTRUCTIVA 0.002 g in 1 mL
RHIZOPUS STOLONIFER (RHIZOPUS STOLONIFER) RHIZOPUS STOLONIFER 0.002 g in 1 mL
PLEOSPORA HERBARUM (PLEOSPORA HERBARUM) PLEOSPORA HERBARUM 0.00008 g in 1 mL
USTILAGO NUDA HORDEI (USTILAGO NUDA HORDEI) USTILAGO NUDA HORDEI 0.0005 g in 1 mL
USTILAGO MAYDIS (USTILAGO MAYDIS) USTILAGO MAYDIS 0.0005 g in 1 mL
USTILAGO AVENAE (USTILAGO AVENAE) USTILAGO AVENAE 0.0005 g in 1 mL
USTILAGO TRITICI (USTILAGO TRITICI) USTILAGO TRITICI 0.0005 g in 1 mL
USTILAGO CYNODONTIS (USTILAGO CYNODONTIS) USTILAGO CYNODONTIS 0.00004 g in 1 mL
SPORISORIUM CRUENTUM (SPORISORIUM CRUENTUM) SPORISORIUM CRUENTUM 0.00004 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL
WATER
GLYCERIN
SODIUM BICARBONATE
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0777-3 10 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
TREATMENT SET TS335101
treatment set ts335101 injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49288-0778
Route of Administration SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CYNODON DACTYLON POLLEN (CYNODON DACTYLON POLLEN) CYNODON DACTYLON POLLEN 16 [BAU] in 1 mL
PLANTAGO LANCEOLATA POLLEN (PLANTAGO LANCEOLATA POLLEN) PLANTAGO LANCEOLATA POLLEN 0.00008 g in 1 mL
JUNIPERUS VIRGINIANA POLLEN (JUNIPERUS VIRGINIANA POLLEN) JUNIPERUS VIRGINIANA POLLEN 0.0004 g in 1 mL
ACER NEGUNDO POLLEN (ACER NEGUNDO POLLEN) ACER NEGUNDO POLLEN 0.00008 g in 1 mL
POPULUS DELTOIDES POLLEN (POPULUS DELTOIDES POLLEN) POPULUS DELTOIDES POLLEN 0.002 g in 1 mL
CARYA ALBA POLLEN (CARYA ALBA POLLEN) CARYA ALBA POLLEN 0.001 g in 1 mL
CARYA ILLINOINENSIS POLLEN (CARYA ILLINOINENSIS POLLEN) CARYA ILLINOINENSIS POLLEN 0.001 g in 1 mL
BETULA NIGRA POLLEN (BETULA NIGRA POLLEN) BETULA NIGRA POLLEN 0.00008 g in 1 mL
FRAXINUS AMERICANA POLLEN (FRAXINUS AMERICANA POLLEN) FRAXINUS AMERICANA POLLEN 0.002 g in 1 mL
QUERCUS ALBA POLLEN (QUERCUS ALBA POLLEN) QUERCUS ALBA POLLEN 0.002 g in 1 mL
SORGHUM HALEPENSE POLLEN (SORGHUM HALEPENSE POLLEN) SORGHUM HALEPENSE POLLEN 0.002 g in 1 mL
KOCHIA SCOPARIA POLLEN (KOCHIA SCOPARIA POLLEN) KOCHIA SCOPARIA POLLEN 0.0004 g in 1 mL
CHENOPODIUM ALBUM POLLEN (CHENOPODIUM ALBUM POLLEN) CHENOPODIUM ALBUM POLLEN 0.0004 g in 1 mL
IVA ANNUA VAR. ANNUA POLLEN (IVA ANNUA VAR. ANNUA POLLEN) IVA ANNUA VAR. ANNUA POLLEN 0.00008 g in 1 mL
AMARANTHUS RETROFLEXUS POLLEN (AMARANTHUS RETROFLEXUS POLLEN) AMARANTHUS RETROFLEXUS POLLEN 0.00008 g in 1 mL
SALSOLA KALI POLLEN (SALSOLA KALI POLLEN) SALSOLA KALI POLLEN 0.0004 g in 1 mL
RUMEX ACETOSELLA POLLEN (RUMEX ACETOSELLA POLLEN) RUMEX ACETOSELLA POLLEN 0.002 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL
WATER
SODIUM CHLORIDE
SODIUM BICARBONATE
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49288-0778-3 10 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA102223 10/31/1986
Labeler — Antigen Laboratories, Inc. (030705628)
Registrant — Antigen Laboratories, Inc. (030705628)
Establishment
Name Address ID/FEI Operations
Antigen Laboratories, Inc. 030705628 manufacture

Revised: 03/2010 Antigen Laboratories, Inc.

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