Label: PROSIRONA- calendula oficinalis flowering top oil
-
Contains inactivated NDC Code(s)
NDC Code(s): 66233-713-01 - Packager: Atlantic Management Resources 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 July 11, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- WARNINGS
- INACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- PURPOSE
- DOSAGE & ADMINISTRATION
- INDICATIONS & USAGE
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
PROSIRONA
calendula oficinalis flowering top oilProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66233-713 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 0.0035 g in 1 g Inactive Ingredients Ingredient Name Strength CAMPHOR OIL, WHITE (UNII: 26P3H26Z9X) 0.05 g in 1 g CORIANDER OIL (UNII: 7626GC95E5) 0.002 g in 1 g ROSEMARY OIL (UNII: 8LGU7VM393) 0.06 g in 1 g MINERAL OIL (UNII: T5L8T28FGP) 0.001 g in 1 g MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) 0.8315 g in 1 g PENNYROYAL OIL (UNII: AK85U7Y3MV) 0.04 g in 1 g ORANGE OIL (UNII: AKN3KSD11B) 0.007 g in 1 g ALMOND OIL (UNII: 66YXD4DKO9) 0.005 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66233-713-01 1 g in 1 BOTTLE, WITH APPLICATOR; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.) 07/04/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/04/2001 Labeler - Atlantic Management Resources Inc. (959409855) Registrant - Atlantic Management Resources Inc. (959409855) Establishment Name Address ID/FEI Business Operations Atlantic Management Resources Inc. 959409855 manufacture(66233-713)
