Arabic Gum (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)
ARABIC GUM
arabic gum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1640
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACACIA (ACACIA) ACACIA 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-1640-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-1640-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-1640-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-1640-4 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
KARAYA GUM
karaya gum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1644
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KARAYA GUM (KARAYA GUM) KARAYA GUM 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-1644-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-1644-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-1644-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-1644-4 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
TRAGACANTH GUM
tragacanth gum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1648
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAGACANTH (TRAGACANTH) TRAGACANTH 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-1648-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-1648-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-1648-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-1648-4 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
DOG FLEA
dog flea injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1802
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CTENOCEPHALIDES CANIS (CTENOCEPHALIDES CANIS) CTENOCEPHALIDES CANIS 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-1802-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-1802-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-1802-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-1802-4 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
CAT FLEA
cat flea injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1846
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CTENOCEPHALIDES FELIS (CTENOCEPHALIDES FELIS) CTENOCEPHALIDES FELIS 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-1846-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-1846-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-1846-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-1846-4 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
ARABIC GUM
arabic gum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1638
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ACACIA (ACACIA) ACACIA 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-1638-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-1638-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-1638-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-1638-4 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
KARAYA GUM
karaya gum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1642
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KARAYA GUM (KARAYA GUM) KARAYA GUM 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-1642-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-1642-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-1642-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-1642-4 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
TRAGACANTH GUM
tragacanth gum injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1646
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRAGACANTH (TRAGACANTH) TRAGACANTH 0.005 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-1646-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-1646-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-1646-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-1646-4 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
DOG FLEA
dog flea injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1803
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CTENOCEPHALIDES CANIS (CTENOCEPHALIDES CANIS) CTENOCEPHALIDES CANIS 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-1803-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-1803-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-1803-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-1803-4 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
CAT FLEA
cat flea injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-1847
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CTENOCEPHALIDES FELIS (CTENOCEPHALIDES FELIS) CTENOCEPHALIDES FELIS 0.01 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-1847-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-1847-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-1847-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-1847-4 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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