Flaxseed (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 Intradermal
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5 mL Stock Scratch
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Stock Small Label
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Stock Large Label
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FLAXSEED
flaxseed injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2217
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLAX SEED (FLAX SEED) FLAX SEED 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2217-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2217-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2217-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2217-4 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
JUTE
jute injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2249
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CORCORUS CAPSULARIS FIBER (CORCORUS CAPSULARIS FIBER) CORCORUS CAPSULARIS FIBER 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2249-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2249-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2249-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2249-4 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
SISAL
sisal injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:36987-2257
Route of Administration INTRADERMAL, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AGAVE SISALANA FIBER (AGAVE SISALANA FIBER) AGAVE SISALANA FIBER 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
SODIUM BICARBONATE
WATER
PHENOL
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:36987-2257-1 5 mL in 1 VIAL, MULTI-DOSE None
2 NDC:36987-2257-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:36987-2257-3 30 mL in 1 VIAL, MULTI-DOSE None
4 NDC:36987-2257-4 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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