Label: H-HEADACHES FORMULA- apium graveolens, nux vomica oil

  • NDC Code(s): 61077-038-11
  • 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 27, 2017

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  • Active Ingredients:

    Apium graveolens - 12C HPUS
    Nux  vomica -12C HPUS

  • Purpose

    Apium graveolens - 12C HPUS (throbbing headaches),
    Nux  vomica -12C HPUS (headache in occiput or over eyes)

    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 (Citrus limon peel,
    Lavandula officinalis flower bud, Matricaria
    recutita flower, Mentha piperita flower and  
    whole plant, Rosmarinus officinalis whole   
    plant).

  • Indications:

    For the temporary relief of headache symptoms such as throbbing pain, pain above the eyes.

  • 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 every 30mins or when needed, no more than 5x 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 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA

  • PRINCIPAL DISPLAY PANEL

    Healing Natural Oils

    H-Headaches

    Formula

    Homeopathic

    For External Use Only

    038

    11ml (0.37 fl. oz)
    amoils.com

    Headaches Label

  • INGREDIENTS AND APPEARANCE
    H-HEADACHES FORMULA 
    apium graveolens, nux vomica oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61077-038
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CELERY SEED (UNII: 1G1EAA320L) (CELERY SEED - UNII:1G1EAA320L) CELERY SEED12 [hp_C]  in 11 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_C]  in 11 mL
    Inactive Ingredients
    Ingredient NameStrength
    EUROPEAN HAZELNUT OIL (UNII: 8RQ2839AVG)  
    LEMON PEEL (UNII: 72O054U628)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    CHAMOMILE (UNII: FGL3685T2X)  
    PEPPERMINT (UNII: V95R5KMY2B)  
    ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61077-038-1111 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(61077-038)
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