ProSirona

PROSIRONA- calendula oficinalis flowering top oil
Atlantic Management Resources Inc.

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.

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PROSIRONA
calendula oficinalis flowering top oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66233-713
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	0.0035 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		07/04/2001

Labeler - Atlantic Management Resources Inc. (959409855)

Registrant - Atlantic Management Resources Inc. (959409855)

Name	Address	ID/FEI	Business Operations
Establishment
Atlantic Management Resources Inc.		959409855	manufacture(66233-713)