Patient Information ⮝
Local reactions to CANDIN can include redness, swelling, pruritus, excoriation and discoloration of the skin. These reactions usually subside within hours or days after administration of the skin test. In some patients, skin discoloration may persist for several weeks. Progression of the DTH reaction to vesiculation, necrosis and ulceration are possible. Patients should be informed that all foreign antigens have the remote possibility of causing Type I anaphylactic reactions that may require the administration of epinephrine and other drugs or emergency procedures and may be life threatening in some cases. Patients should report any serious adverse reactions to their health care provider.
Sections or subsections omitted from the full prescribing information are not listed.
PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - VIAL
Candida albicansSkin Test Antigen For Cellular Hypersensitivity
CANDIN
NDC 59584-138-01 1D barcode: 59584-138-01
Volume: 1 mL (10 Tests)
Dose: 0.1 mL Intradermally
See Package Insert
Store: 2-8 C Rx Only
Preservative: 0.4% PHENOL
Mfd. for Nielsen BioSciences, Inc.
San Diego CA 921212D barcode
Lot:
Exp:PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - CARTON
DOSE: 0.1 mL intradermally. See circular. (panel 1)
CONTENTS: 1 mL multidose vial (ten tests).
INGREDIENTS:Candidaantigen in buffered saline with 0.03% albumin USP, 8ppm polysorbate 80 and phenol 0.4% as a preservative.
Rev 9/15
Lot: CAxxx(on end flap)
Expiration Date: (on end flap)Candida albicansSkin Test Antigen to Assess Cellular Hypersensitivity(panel 2)
CANDINSkin Test Strength
For use in assessing cell-mediated or delayed-type
hypersensitivity toCandida albicans.Mfd. for Nielsen BioSciences, Inc., U.S. License 1903
San Diego, CA 92121
Potency: Measured by delayed-type intradermal
skin tests in humans. (panel 3)Storage: Store at 2-8 C (35-46 F). Do not freeze.
No U.S. Standard of Potency.
Rx only.
1D barcode: 59584-138-01 (4th panel)
2D GS1 serialized barcode (on end flap)
CANDIN
candida albicans skin test antigen injection, solution
Product Information Product Type STANDARDIZED ALLERGENIC Item Code (Source) NDC:59584-138 Route of Administration INTRADERMAL
Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS(UNII: 4D7G21HDBC) (CANDIDA ALBICANS - UNII:4D7G21HDBC) CANDIDA ALBICANS 1 U in 0.1 mL
Inactive Ingredients Ingredient Name Strength ALBUMIN HUMAN(UNII: ZIF514RVZR) 0.03 mg in 0.1 mL SODIUM CHLORIDE(UNII: 451W47IQ8X) 0.5 mg in 0.1 mL SODIUM BICARBONATE(UNII: 8MDF5V39QO) 0.25 mg in 0.1 mL POLYSORBATE 80(UNII: 6OZP39ZG8H) 0.8 ug in 0.1 mL PHENOL(UNII: 339NCG44TV) 0.4 mg in 0.1 mL WATER(UNII: 059QF0KO0R)
Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59584-138-01 1 mL in 1 VIAL, MULTI-DOSE; Type 0: Not a Combination Product
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103257 12/01/1995
Labeler -Nielsen BioSciences, Inc. (078835288)
Registrant -Nielsen BioSciences, Inc. (078835288)
Establishment Name Address ID/FEI Business Operations Allermed Laboratories, Inc. 073364531 manufacture
Establishment Name Address ID/FEI Business Operations Nielsen BioSciences, Inc. 078835288 manufacture
Revised: 1/2018document Id: ⮝
d44377f4-9394-4e36-a5d0-a980ab30ccefSet id: 4254e4c8-4a44-4766-8caf-61c65dc3267cVersion: 15Effective Time: 20180103Nielsen BioSciences, Inc.