PROSIRONA- calendula oficinalis flowering top oil

United States - English - NLM (National Library of Medicine)

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Active ingredient:
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)
Available from:
Atlantic Management Resources Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Authorization status:
unapproved homeopathic
Authorization number:
66233-713-01

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

PROSIRONA

calendula oficinalis flowering top oil

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 6 233-713

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

CALENDULA O FFICINALIS FLO WERING TO P (UNII: 18 E7415PXQ) (CALENDULA

OFFICINALIS FLOWERING TOP - UNII:18 E7415PXQ)

CALENDULA OFFICINALIS

FLOWERING TOP

0 .0 0 35 g

in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

CAMPHO R O IL, WHITE (UNII: 26 P3H26 Z9 X)

0 .0 5 g in 1 g

CO RIANDER O IL (UNII: 76 26 GC9 5E5)

0 .0 0 2 g in 1 g

RO SEMARY O IL (UNII: 8 LGU7VM39 3)

0 .0 6 g in 1 g

MINERAL O IL (UNII: T5L8 T28 FGP)

0 .0 0 1 g in 1 g

MENTHA ARVENSIS LEAF O IL (UNII: 1AEY1M553N)

0 .8 315 g in 1 g

PENNYRO YAL O IL (UNII: AK8 5U7Y3MV)

0 .0 4 g in 1 g

O RANGE O IL (UNII: AKN3KSD11B)

0 .0 0 7 g in 1 g

ALMO ND O IL (UNII: 6 6 YXD4DKO9 )

0 .0 0 5 g in 1 g

Atlantic Management Resources Inc.

Packag ing

#

Item Code

Package Description

Marketing

Start Date

Marketing

End Date

1

NDC:6 6 233-

713-0 1

1 g in 1 BOTTLE, WITH APPLICATOR; Type 2: Prefilled Drug Delivery

Device/System (syringe, patch, etc.)

0 7/0 4/20 20

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

unappro ved ho meo pathic

0 7/0 4/20 0 1

Labeler -

Atlantic Management Resources Inc. (959409855)

Registrant -

Atlantic Management Resources Inc. (959409855)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Atlantic Management Reso urces Inc.

9 59 40 9 8 55

ma nufa c ture (6 6 233-713)

Revised: 1/2020

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