Label: H-ROSACEA FORMULA- belladonna, nux vomica oil

  • NDC Code(s): 61077-121-11, 61077-121-33
  • 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 27, 2017

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  • Active Ingredients:

    Belladonna - 6C HPUS
    Nux vomica -12C HPUS  

  • Purpose

    Belladonna - 6C HPUS (rosacea, acne)
    Nux vomica -12C HPUS (skin red and blotchy)

    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 (Cupressus   
    sempervirens leaves and twigs, Daucus carota seed, Helichrysum italicum flower,   
    Lavandula officinalis flower bud, Matricaria recutita flower, Melaleuca alternifolia   
    leaf-branch, Pelargonium graveolens whole plant).

  • Indications:

    For the temporary relief of rosacea symptoms such as redness and irritation

  • Directions:

    Adults and Children 4 yrs and over: Wash hands before and after use.
    Shake well and apply 1 or 2 drops to a cotton swab or your fingers and apply directly to the affected area 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 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA

  • PRINCIPAL DISPLAY PANEL

    Healing Natural Oils

    H-Rosacea
    Formula

    Homeopathic

    For External Use Only

    121

    11ml (0.37 fl. oz)
    amoils.com

    Rosacea Label

  • INGREDIENTS AND APPEARANCE
    H-ROSACEA FORMULA  
    belladonna, nux vomica oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61077-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [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)  
    CUPRESSUS SEMPERVIRENS LEAFY TWIG (UNII: 7HB6L93P3U)  
    LAVANDULA ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    CHAMOMILE (UNII: FGL3685T2X)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    PELARGONIUM GRAVEOLENS WHOLE (UNII: 0E553RP62F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61077-121-1111 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    2NDC:61077-121-3333 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(61077-121)
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