국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)
Atlantic Management Resources Inc.
TOPICAL
OTC DRUG
unapproved homeopathic
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._ ---------- PROSIRONA 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 Atlantic Management Resources Inc. 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) Revised: 7/2022 전체 문서 읽기