Label: H-ACNE FORMULA- calendula officinalis, nux vomica, silicea oil

  • NDC Code(s): 61077-020-11, 61077-020-33
  • 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:

    Calendula officinalis-12C HPUS,
    Nux vomica -12C HPUS,
    Silicea 12C HPUS

  • Purpose

    Calendula officinalis -12C HPUS (healing agent), 
    Nux vomica-12C  HPUS  (acne,  skin red),
    Silicea 12C HPUS  (for blotches on skin)

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

  • Inactive Ingredients:

    Essential Oil Blend (Cymbopogon martinii aerial parts,
    Daucus carota seed,   Helichrysum  italicum  flower,
    Lavandula  officinalis flower bud,  Melaleuca
    alternifolia leaf-branch, Pelargonium
    graveolens whole plant)

  • Indications:

    For the temporary relief of the symptoms of acne, blemishes and pimples.

  • 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 finger 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-Acne
    Formula

    Homeopathic

    For External Use Only

    020

    11ml (0.37 fl. oz)
    amoils.com

    Acne Label

  • INGREDIENTS AND APPEARANCE
    H-ACNE FORMULA  
    calendula officinalis, nux vomica, silicea oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61077-020
    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 TOP12 [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
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_C]  in 11 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYMBOPOGON MARTINI TOP (UNII: 7K1N3UZ6DU)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    HELICHRYSUM ITALICUM FLOWER (UNII: P62Y550X24)  
    PELARGONIUM GRAVEOLENS WHOLE (UNII: 0E553RP62F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61077-020-1111 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    2NDC:61077-020-3333 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 Inc.617901350manufacture(61077-020)
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