Label: NEUROQUELL-PLUS 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 July 11, 2022

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient

  • WARNINGS

    Warnings

  • INACTIVE INGREDIENT

    Inactive Ingredients

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of Children

  • PURPOSE

    OTC Purpose section

  • DOSAGE & ADMINISTRATION SECTION

    When you are ready to apply Neuroquell, remove the cap, turn the bottle upside down, and gently roll the applicator onto the area of discomfort in a continuous, back-and-forth motion to cover approximately one-half of the area of your pain. If using either the sample swab or towelette, apply in a similar way. Your skin will remain moist for a few minutes. Close cap tightly after use, and wash hands thoroughly. Feel free to reapply 4-to-6 hours later and up to 3 additional times per day. To eliminate the peppermint scent, you can wash the treated area with soap and water 15 minutes after the application. This will not affect the efficacy of the product. If there is highlights text then the SPL document title should include the following text string without quotation marks: These highlights do not include all the information needed to use see full prescribing information for and Initial U.S. Approval

  • INDICATIONS & USAGE SECTION

    Temporarily relieves pain associated with minor aches and pains of muscles, joints, nerve-based pain and headaches/migraines. Individual results may vary.

  • PRINCIPAL DISPLAY PANEL

    Neuroquell-Plus Label

  • INGREDIENTS AND APPEARANCE
    NEUROQUELL-PLUS 
    neuroquell-plus oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66233-714
    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 TOP0.015 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MINERAL OIL (UNII: T5L8T28FGP) 0.001 g  in 1 g
    ALMOND OIL (UNII: 66YXD4DKO9) 0.005 g  in 1 g
    MENTHA ARVENSIS LEAF OIL (UNII: 1AEY1M553N) 0.82 g  in 1 g
    ORANGE OIL (UNII: AKN3KSD11B) 0.007 g  in 1 g
    CAMPHOR OIL, WHITE (UNII: 26P3H26Z9X) 0.05 g  in 1 g
    CORIANDER OIL (UNII: 7626GC95E5) 0.002 g  in 1 g
    PENNYROYAL OIL (UNII: AK85U7Y3MV) 0.04 g  in 1 g
    ROSEMARY OIL (UNII: 8LGU7VM393) 0.06 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66233-714-011 g in 1 BOTTLE, WITH APPLICATOR; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)07/04/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/05/2004
    Labeler - Atlantic Management Resources Inc (959409855)
    Registrant - Atlantic Management Resources Inc (959409855)
    Establishment
    NameAddressID/FEIBusiness Operations
    Atlantic Management Resources Inc959409855manufacture(66233-714)