Label: H-INSOMNIA FORMULA- apium graveolens, salvia officinalis oil

  • NDC Code(s): 61077-117-11, 61077-117-33
  • Packager: Healing Natural Oils LLC
  • 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 11, 2024

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  • Active Ingredients:

    Apium graveolens - 6C HPUS
    Salvia officinalis - 6C HPUS  

  • Purpose

    Apium graveolens - 6C HPUS (soporific active principle)

    Salvia officinalis - 6C HPUS (insomnia and night sweats)

    The letters ‘HPUS’ indicate that the components in this product are officially
    monographed in the Homoeopathic Pharmacopoeia of the United States


  • Inactive Ingredients:

    Corylus
 avellana
 nut
 oil, 
Essential
 Oil 
Blend
 (Cedrus atlantica   
    wood shavings, Lavandula officinalis flower bud, Melissa officinalis blossoms and  
    whole plant).

  • Indications:

    For the temporary relief of insomnia and sleeplessness.

  • Directions:

    Adults and Children 4 yrs and over: Wash hands before and after use.
    Shake well and apply 1 or 2 drops to fingers and massage temples and back of neck 30 mins before sleep or when needed, no more than 3x per day.
    Do not oversaturate or exceed dosage.

  • Warnings:

    For external use only.

    Perform skin test prior to initial use.





    Do not use if pregnant or breastfeeding.

    Keep out of reach of children.

    Keep away from eyes and mucous membranes. If swallowed get medical help

    or contact a Poison Control Center right away.

    Discontinue use if irritation occurs.

    Consult a doctor if symptoms worsen after 7 days.

  • DESCRIPTION

    Dist. by Healing Natural Oils 1042 N El Camino Real,

    #B-426, Encinitas, CA 92024 USA

  • Principal Display Panel

    Healing Natural Oils

    H-Insomnia

    Formula

    Homeopathic

    For External Use Only

    117

    11ml (0.37 fl. oz)

    amoils.com


    H-Insomnia Formula-11ml.jpg

  • INGREDIENTS AND APPEARANCE
    H-INSOMNIA FORMULA 
    apium graveolens, salvia officinalis oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61077-117
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CELERY SEED (UNII: 1G1EAA320L) (CELERY SEED - UNII:1G1EAA320L) CELERY SEED6 [hp_C]  in 11 mL
    SAGE (UNII: 065C5D077J) (SAGE - UNII:065C5D077J) SAGE6 [hp_C]  in 11 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)  
    CEDRUS ATLANTICA BARK OIL (UNII: ZX5QRE4U60)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    MELISSA OFFICINALIS (UNII: YF70189L0N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61077-117-1111 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    2NDC:61077-117-3333 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/06/2013
    Labeler - Healing Natural Oils LLC (113679703)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc617901350manufacture(61077-117)
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