Daisy: Package Insert and Label Information (Page 3 of 3)

17 PATIENT COUNSELING INFORMATION

Instruct patient to remain under observation in the office for 30 minutes or longer after an injection.

Caution patient that reactions can occur more than 30 minutes after skin testing or an injection.

Instruct patient to recognize the following symptoms as adverse reactions and to immediately return to the office or immediately seek other medical attention if any of these symptoms occur following skin testing or an injection:

  • Unusual swelling and/or tenderness at the injection site
  • Hives or itching of the skin
  • Swelling of the face and/or mouth
  • Sneezing, coughing or wheezing
  • Shortness of breath
  • Nausea
  • Dizziness or faintness

Manufacturer:

U.S. License No. 308

Greer Laboratories, Inc.

Lenoir, NC 28645 U.S.A

5500-5_Daisy_20-wv
(click image for full-size original)

1502-1_Dandelion_1000-wv
(click image for full-size original)
5502-4_Sunflower_20-wv
(click image for full-size original)
1504-2_Sunflower_40000-pnu
(click image for full-size original)
DAISY leucanthemum vulgare solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:22840-1570
Route of Administration INTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEUCANTHEMUM VULGARE POLLEN (LEUCANTHEMUM VULGARE POLLEN) LEUCANTHEMUM VULGARE POLLEN 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE
PHENOL
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:22840-1570-2 10 mL in 1 VIAL, MULTI-DOSE None
2 NDC:22840-1570-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101833 09/15/1981
DANDELION taraxacum officinale solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:22840-1502
Route of Administration PERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TARAXACUM OFFICINALE POLLEN (TARAXACUM OFFICINALE POLLEN) TARAXACUM OFFICINALE POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE
SODIUM CHLORIDE
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:22840-1502-1 5 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101833 09/15/1981
DANDELION taraxacum officinale solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:22840-1501
Route of Administration PERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TARAXACUM OFFICINALE POLLEN (TARAXACUM OFFICINALE POLLEN) TARAXACUM OFFICINALE POLLEN 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE
SODIUM CHLORIDE
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:22840-1501-1 5 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101833 09/15/1981
DANDELION taraxacum officinale solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:22840-1572
Route of Administration PERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TARAXACUM OFFICINALE POLLEN (TARAXACUM OFFICINALE POLLEN) TARAXACUM OFFICINALE POLLEN 20000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE
SODIUM CHLORIDE
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:22840-1572-2 10 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101833 09/15/1981
DAISY leucanthemum vulgare solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:22840-1569
Route of Administration INTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEUCANTHEMUM VULGARE POLLEN (LEUCANTHEMUM VULGARE POLLEN) LEUCANTHEMUM VULGARE POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE
PHENOL
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:22840-1569-2 10 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101833 09/15/1981
SUNFLOWER helianthus annuus solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:22840-1503
Route of Administration INTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HELIANTHUS ANNUUS POLLEN (HELIANTHUS ANNUUS POLLEN) HELIANTHUS ANNUUS POLLEN 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE
PHENOL
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:22840-1503-2 10 mL in 1 VIAL, MULTI-DOSE None
2 NDC:22840-1503-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101833 09/15/1981
DANDELION taraxacum officinale solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:22840-5501
Route of Administration PERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TARAXACUM OFFICINALE POLLEN (TARAXACUM OFFICINALE POLLEN) TARAXACUM OFFICINALE POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL
SODIUM BICARBONATE
SODIUM CHLORIDE
GLYCERIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:22840-5501-5 5 mL in 1 BOTTLE, DROPPER None
2 NDC:22840-5501-2 10 mL in 1 VIAL, MULTI-DOSE None
3 NDC:22840-5501-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101833 09/15/1981
DANDELION taraxacum officinale solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:22840-1571
Route of Administration PERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TARAXACUM OFFICINALE POLLEN (TARAXACUM OFFICINALE POLLEN) TARAXACUM OFFICINALE POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL
SODIUM BICARBONATE
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:22840-1571-2 10 mL in 1 VIAL, MULTI-DOSE None
2 NDC:22840-1571-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101833 09/15/1981
SUNFLOWER helianthus annuus solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:22840-1506
Route of Administration INTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HELIANTHUS ANNUUS POLLEN (HELIANTHUS ANNUUS POLLEN) HELIANTHUS ANNUUS POLLEN 0.001 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE
PHENOL
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:22840-1506-1 5 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101833 09/15/1981
DANDELION taraxacum officinale solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:22840-1573
Route of Administration PERCUTANEOUS, SUBCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TARAXACUM OFFICINALE POLLEN (TARAXACUM OFFICINALE POLLEN) TARAXACUM OFFICINALE POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE
SODIUM CHLORIDE
PHENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:22840-1573-2 10 mL in 1 VIAL, MULTI-DOSE None
2 NDC:22840-1573-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101833 09/15/1981
SUNFLOWER helianthus annuus solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:22840-1504
Route of Administration INTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HELIANTHUS ANNUUS POLLEN (HELIANTHUS ANNUUS POLLEN) HELIANTHUS ANNUUS POLLEN 40000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE
PHENOL
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:22840-1504-2 10 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101833 09/15/1981
SUNFLOWER helianthus annuus solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:22840-5502
Route of Administration INTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HELIANTHUS ANNUUS POLLEN (HELIANTHUS ANNUUS POLLEN) HELIANTHUS ANNUUS POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
SODIUM BICARBONATE
PHENOL
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:22840-5502-2 10 mL in 1 VIAL, MULTI-DOSE None
2 NDC:22840-5502-4 50 mL in 1 VIAL, MULTI-DOSE None
3 NDC:22840-5502-5 5 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101833 09/15/1981
DAISY leucanthemum vulgare solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:22840-5500
Route of Administration INTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEUCANTHEMUM VULGARE POLLEN (LEUCANTHEMUM VULGARE POLLEN) LEUCANTHEMUM VULGARE POLLEN 0.05 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN
SODIUM BICARBONATE
PHENOL
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:22840-5500-2 10 mL in 1 VIAL, MULTI-DOSE None
2 NDC:22840-5500-5 5 mL in 1 BOTTLE, DROPPER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101833 09/15/1981
DANDELION taraxacum officinale solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:22840-1500
Route of Administration SUBCUTANEOUS, PERCUTANEOUS, INTRADERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TARAXACUM OFFICINALE POLLEN (TARAXACUM OFFICINALE POLLEN) TARAXACUM OFFICINALE POLLEN 0.1 g in 1 mL
Inactive Ingredients
Ingredient Name Strength
PHENOL
SODIUM BICARBONATE
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:22840-1500-2 10 mL in 1 VIAL, MULTI-DOSE None
2 NDC:22840-1500-4 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101833 09/15/1981
SUNFLOWER helianthus annuus solution
Product Information
Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:22840-1505
Route of Administration INTRADERMAL, PERCUTANEOUS, SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
HELIANTHUS ANNUUS POLLEN (HELIANTHUS ANNUUS POLLEN) HELIANTHUS ANNUUS POLLEN 1000 [PNU] in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM BICARBONATE
PHENOL
SODIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:22840-1505-1 5 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA101833 09/15/1981
Labeler — Greer Laboratories, Inc. (024671414)
Registrant — Greer Laboratories, Inc. (024671414)
Establishment
Name Address ID/FEI Operations
Greer Laboratories, Inc. 024671414 manufacture (22840-1100), manufacture (22840-1101), manufacture (22840-1102), manufacture (22840-1103), manufacture (22840-1105), manufacture (22840-1106), manufacture (22840-1107), manufacture (22840-1108), manufacture (22840-1110), manufacture (22840-1111), manufacture (22840-1112), manufacture (22840-1113), manufacture (22840-1116), manufacture (22840-1117), manufacture (22840-1118), manufacture (22840-1119), manufacture (22840-1121), manufacture (22840-1122), manufacture (22840-1123), manufacture (22840-1125), manufacture (22840-1126), manufacture (22840-1127), manufacture (22840-1128), manufacture (22840-1129), manufacture (22840-1130), manufacture (22840-1131), manufacture (22840-1133), manufacture (22840-1134), manufacture (22840-1135), manufacture (22840-1136), manufacture (22840-1138), manufacture (22840-1139), manufacture (22840-1140), manufacture (22840-1141), manufacture (22840-1142), manufacture (22840-1144), manufacture (22840-1145), manufacture (22840-1146), manufacture (22840-1147), manufacture (22840-1149), manufacture (22840-1150), manufacture (22840-1151), manufacture (22840-1153), manufacture (22840-1154), manufacture (22840-1155), manufacture (22840-1157), manufacture (22840-1159), manufacture (22840-1160), manufacture (22840-1162), manufacture (22840-1163), manufacture (22840-1164), manufacture (22840-1167), manufacture (22840-1168), manufacture (22840-1169), manufacture (22840-1170), manufacture (22840-1171), manufacture (22840-1173), manufacture (22840-1174), manufacture (22840-1175), manufacture (22840-1176), manufacture (22840-1537), manufacture (22840-1538), manufacture (22840-5100), manufacture (22840-5101), manufacture (22840-5102), manufacture (22840-5103), manufacture (22840-5104), manufacture (22840-5105), manufacture (22840-5106), manufacture (22840-5107), manufacture (22840-5108), manufacture (22840-5109), manufacture (22840-5110), manufacture (22840-5111), manufacture (22840-5112), manufacture (22840-5113), manufacture (22840-5114), manufacture (22840-5115), manufacture (22840-5517), manufacture (22840-9100), manufacture (22840-9101), manufacture (22840-9102), manufacture (22840-9103), manufacture (22840-9104), manufacture (22840-9105), manufacture (22840-9107)

Revised: 11/2019 Greer Laboratories, Inc.

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