Label: CANDIDA- candida parapsilosis spray
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Contains inactivated NDC Code(s)
NDC Code(s): 54256-099-05 - Packager: BioResource Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.
Drug Label Information
Updated September 2, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Indications
- Dosage
- Ingredients
- Warning
- Tamper Evident
- QUESTIONS
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 ml Bottle Box
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INGREDIENTS AND APPEARANCE
CANDIDA
candida parapsilosis sprayProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54256-099 Route of Administration NASAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Candida parapsilosis (UNII: 0KZ676D44N) (Candida parapsilosis - UNII:0KZ676D44N) Candida parapsilosis 4 [hp_X] in 15 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Sodium chloride (UNII: 451W47IQ8X) Potassium sorbate (UNII: 1VPU26JZZ4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54256-099-05 1 in 1 BOX 08/01/2016 1 15 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date UNAPPROVED HOMEOPATHIC 08/01/2016 Labeler - BioResource Inc. (017532917) Establishment Name Address ID/FEI Business Operations Sophien Arzneimittel GmbH 537313459 MANUFACTURE(54256-099)