Label: SLEEP AID TINCTURE- cannabidinol oil

  • NDC Code(s): 82876-226-24
  • Packager: Carolina cannabis creations L.L.C
  • 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 December 21, 2022

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

View All Sections
  • Active ingredients

    Cannabidiol 4%

    Cannabinol 1%

    Mentha piperita (Peppermint) 2%

    Purpose

    Cannabidiol 4%..........Nighttime sleep-aid

    Cannabinol 1%...........Nighttime sleep-aid

    Mentha piperita 1%........Nighttime sleep-aid

  • Uses

    temporary relief from symptoms associated with anxiety, fatigue, insomnia, stress, restlessness

  • Warnings

    when using this product, do not use if seal is broken, if you are allergic to the listed ingredients

  • stop use and ask a doctor if

    condition persists or worsens

    Stop use and ask doctor if

    condition persists or worsens

  • if pregnant or breast feeding

    consult a health professional before use

    in case of overdose

    seek medical help or contact a posion control center right away

  • Directions

    Adults and children 12 years and over; place 0.5-1mL under tounge and hold for 30 seconds, swallow remainder, use nightly or as needed

    children under 12 years; consult a doctor

    keep out of reach of children

    Keep out of reach of children

  • inactive ingredients

    cocos nucifera (fractionated coconut) oil

  • other safety information

    store at 68-77 degrees F, avoid direct sunight

  • bottle label

    bottle label

  • INGREDIENTS AND APPEARANCE
    SLEEP AID TINCTURE 
    cannabidinol oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82876-226
    Route of AdministrationSUBLINGUAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CANNABIDIOL (UNII: 19GBJ60SN5) (CANNABIDIOL - UNII:19GBJ60SN5) CANNABIDIOL1.26 g  in 30 g
    CANNABINOL (UNII: 7UYP6MC9GH) (CANNABINOL - UNII:7UYP6MC9GH) CANNABINOL0.31 g  in 30 g
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL0.6 g  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L) 27.83 g  in 30 g
    Product Characteristics
    ColorbrownScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82876-226-2430 g in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product12/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/20/2022
    Labeler - Carolina cannabis creations L.L.C (118697474)
    Establishment
    NameAddressID/FEIBusiness Operations
    Carolina Cannabis Creations L.L.C118697474manufacture(82876-226)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!