Egg White (Page 3 of 3)

HOW SUPPLIED

Allergenic extracts are supplied with units listed as: Weight/volume (W/V), Protein Nitrogen Units (PNU/ml), Allergy Units (AU/ml) or Bioequivalent Allergy Units (BAU/ml).

Sizes:

Diagnostic Scratch: 5 ml dropper application vials

Diagnostic Intradermal: 5 ml or 10 ml vials.

Therapeutic Allergens: 5 ml, 10 ml, 50 ml multiple dose vials.

STORAGE

The expiration date of allergen extracts is listed on the container label. Store extracts upon arrival at 2° to 8°C and keep them in this range during office use.

WARRANTY: We warrant that this product was prepared and tested according to the standards of the FDA and is true to label. Because of biological differences in individuals and because allergenic extracts are manufactured to be potent and because we have no control over the conditions of use, we cannot and do not warrant either a good effect or against an ill effect following use.

REFERENCES

1 Jacobs, Robert L., Geoffrey W.Rake,Jr., et.al. Potentiated Anaphylaxis in Patients with Drug-induced Beta-adrenergic Blockade. J.Allergy & Clin. Immunol., 68(2): 125-127. August 1981.

2 Ishizaka,K.: Cellular Events in the IgE Antibody Response. Adv. in Immuno. 23:50-75, 1976.

3. Lockey, R.F., Bukantz, S.C., Allergen Immunotherapy. New York,NY: Marcel Dekker Inc., 1991.

4. Reid,M.J., Lockey,R.F., Turkeltaub,P.C., Platts-Mills,T.A.E., Survey of fatalities from skin testing and immunotherapy 1985-1989. Journal of Allergy Clin. Immunol. 92 (1): 6-15, July 1993.

5. Murray, A.B., Ferguson, A., Morrison, B., The frequency and severity of cat allergy vs dog allergy in atopic children. J. Allergy Clin. Immunolo: 72, 145-9, 1983.

6. Lockey, R.F., Bukantz, S.C., Allergen Immunotherapy. New York,NY: Marcel Dekker Inc., 1991.

CONTAINER LABELING

EGG WHITE egg white injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1130 Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EGG WHITE (EGG WHITE) EGG WHITE 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE PHENOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:36987-1130-1 5 mL in 1 VIAL, MULTI-DOSE None 2 NDC:36987-1130-2 10 mL in 1 VIAL, MULTI-DOSE None 3 NDC:36987-1130-3 30 mL in 1 VIAL, MULTI-DOSE None 4 NDC:36987-1130-4 50 mL in 1 VIAL, MULTI-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

EGG YOLK egg yolk injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1134 Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EGG YOLK (EGG YOLK) EGG YOLK 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE PHENOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:36987-1134-1 5 mL in 1 VIAL, MULTI-DOSE None 2 NDC:36987-1134-2 10 mL in 1 VIAL, MULTI-DOSE None 3 NDC:36987-1134-3 30 mL in 1 VIAL, MULTI-DOSE None 4 NDC:36987-1134-4 50 mL in 1 VIAL, MULTI-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

WHOLE EGG whole egg injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1138 Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EGG (EGG) EGG 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE PHENOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:36987-1138-1 5 mL in 1 VIAL, MULTI-DOSE None 2 NDC:36987-1138-2 10 mL in 1 VIAL, MULTI-DOSE None 3 NDC:36987-1138-3 30 mL in 1 VIAL, MULTI-DOSE None 4 NDC:36987-1138-4 50 mL in 1 VIAL, MULTI-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

BEEF beef injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1142 Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BEEF (BEEF) BEEF 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE PHENOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:36987-1142-1 5 mL in 1 VIAL, MULTI-DOSE None 2 NDC:36987-1142-2 10 mL in 1 VIAL, MULTI-DOSE None 3 NDC:36987-1142-3 30 mL in 1 VIAL, MULTI-DOSE None 4 NDC:36987-1142-4 50 mL in 1 VIAL, MULTI-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

CHICKEN MEAT chicken meat injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1146 Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHICKEN (CHICKEN) CHICKEN 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE PHENOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:36987-1146-1 5 mL in 1 VIAL, MULTI-DOSE None 2 NDC:36987-1146-2 10 mL in 1 VIAL, MULTI-DOSE None 3 NDC:36987-1146-3 30 mL in 1 VIAL, MULTI-DOSE None 4 NDC:36987-1146-4 50 mL in 1 VIAL, MULTI-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

DUCK MEAT duck meat injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1150 Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DUCK (DUCK) DUCK 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE PHENOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:36987-1150-1 5 mL in 1 VIAL, MULTI-DOSE None 2 NDC:36987-1150-2 10 mL in 1 VIAL, MULTI-DOSE None 3 NDC:36987-1150-3 30 mL in 1 VIAL, MULTI-DOSE None 4 NDC:36987-1150-4 50 mL in 1 VIAL, MULTI-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

LAMB lamb injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1154 Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LAMB (LAMB) LAMB 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE PHENOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:36987-1154-1 5 mL in 1 VIAL, MULTI-DOSE None 2 NDC:36987-1154-2 10 mL in 1 VIAL, MULTI-DOSE None 3 NDC:36987-1154-3 30 mL in 1 VIAL, MULTI-DOSE None 4 NDC:36987-1154-4 50 mL in 1 VIAL, MULTI-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

BEEF LIVER beef liver injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1158 Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALLERGENIC EXTRACT- BEEF LIVER (ALLERGENIC EXTRACT- BEEF LIVER) ALLERGENIC EXTRACT- BEEF LIVER 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE PHENOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:36987-1158-1 5 mL in 1 VIAL, MULTI-DOSE None 2 NDC:36987-1158-2 10 mL in 1 VIAL, MULTI-DOSE None 3 NDC:36987-1158-3 30 mL in 1 VIAL, MULTI-DOSE None 4 NDC:36987-1158-4 50 mL in 1 VIAL, MULTI-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

PORK pork injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1162 Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PORK (PORK) PORK 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE PHENOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:36987-1162-1 5 mL in 1 VIAL, MULTI-DOSE None 2 NDC:36987-1162-2 10 mL in 1 VIAL, MULTI-DOSE None 3 NDC:36987-1162-3 30 mL in 1 VIAL, MULTI-DOSE None 4 NDC:36987-1162-4 50 mL in 1 VIAL, MULTI-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

TURKEY turkey injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1166 Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TURKEY (TURKEY) TURKEY 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE PHENOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:36987-1166-1 5 mL in 1 VIAL, MULTI-DOSE None 2 NDC:36987-1166-2 10 mL in 1 VIAL, MULTI-DOSE None 3 NDC:36987-1166-3 30 mL in 1 VIAL, MULTI-DOSE None 4 NDC:36987-1166-4 50 mL in 1 VIAL, MULTI-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

VEAL veal injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1170 Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VEAL (VEAL) VEAL 0.05 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM BICARBONATE PHENOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:36987-1170-1 5 mL in 1 VIAL, MULTI-DOSE None 2 NDC:36987-1170-2 10 mL in 1 VIAL, MULTI-DOSE None 3 NDC:36987-1170-3 30 mL in 1 VIAL, MULTI-DOSE None 4 NDC:36987-1170-4 50 mL in 1 VIAL, MULTI-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA102192 08/29/1972

Labeler — Nelco Laboratories, Inc. (054980867)

Registrant — Nelco Laboratories, Inc. (054980867)

Establishment
Name	Address	ID/FEI	Operations
Nelco Laboratories, Inc.		054980867	manufacture

Revised: 12/2009 Nelco Laboratories, Inc.