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

5 mL Stock Concentrate Scratch
(click image for full-size original)
5 mL Stock Concentrate Intradermal
(click image for full-size original)
Stock Concentrate Small Label
(click image for full-size original)
Stock Concentrate Large Label
(click image for full-size original)
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.

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