PROSIRONA- calendula oficinalis flowering top oil

ProSirona by

Drug Labeling and Warnings

ProSirona by is a Homeopathic medication manufactured, distributed, or labeled by Atlantic Management Resources Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 oil

Product 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)