Label: MENASTIL- calendula officinalis flowering top oil

  • 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 March 29, 2021

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  • ACTIVE INGREDIENT

    Active Ingredients

  • WARNINGS

    Warnings

  • INACTIVE INGREDIENT

    Inactive Ingredients

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of Children

  • PURPOSE

    OTC Purpose

  • DOSAGE & ADMINISTRATION

    Dosage and Admin

  • INDICATIONS & USAGE

    Indications and usage

  • PRINCIPAL DISPLAY PANEL

    Menastil Label

  • INGREDIENTS AND APPEARANCE
    MENASTIL 
    calendula officinalis flowering top oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66233-711
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP0.0025 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR OIL, WHITE (UNII: 26P3H26Z9X) 0.05 g  in 1 g
    ROSEMARY OIL (UNII: 8LGU7VM393) 0.06 g  in 1 g
    MINERAL OIL (UNII: T5L8T28FGP) 0.001 g  in 1 g
    ALMOND OIL (UNII: 66YXD4DKO9) 0.005 g  in 1 g
    PENNYROYAL OIL (UNII: AK85U7Y3MV) 0.04 g  in 1 g
    CORIANDER OIL (UNII: 7626GC95E5) 0.002 g  in 1 g
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) 0.8325 g  in 1 g
    ORANGE OIL (UNII: AKN3KSD11B) 0.007 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66233-711-011 g in 1 BOTTLE, WITH APPLICATOR; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)07/04/2001
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/04/2001
    Labeler - Atlantic Management Resources Inc (959409855)
    Registrant - Atlantic Management Resources Inc (959409855)
    Establishment
    NameAddressID/FEIBusiness Operations
    Atlantic Management Resources Inc959409855manufacture(66233-711)