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

  • 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 March 13, 2012

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:  alendula officinalis 12C HPUS, Nux vomica 12C HPUS, Silicea 12C HPUS.

  • PURPOSE

    INDICATIONS:  For the temporary relief of the symptoms of acne, blemishes and pimples.
  • WARNINGS

    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 irritations occurs.

    Consult a doctor if symptoms worsen after 7 days.

  • DOSAGE & ADMINISTRATION

    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.

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS:  Cymbopogon martinii aerial parts, Daucus carota seed, Helichrysum italicum flower, Lavandula officinalis flower bud, Melaleuca alternifolia leaf-branch, Pelargonium graveolens whole plant, Ethanol.

  • KEEP OUT OF REACH OF CHILDREN

    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.

  • INDICATIONS & USAGE

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

  • QUESTIONS

    Dist. by Healing Natural Oils

    1042 N El Camino Real #B-426

    Encinitas, CA 92024 USA

    The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.


  • PRINCIPAL DISPLAY PANEL

    Healing Natural Oils

    H Acne Formula

    Homeopathic

    For External Use Only

    045

    33ml (1.12 fl. oz)

    H-Acne Formula

  • INGREDIENTS AND APPEARANCE
    H ACNE FORMULA 
    calendula officinalis, nux vomica, silicea, oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57520-1111
    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 1 mL
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED12 [hp_C]  in 1 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    PALMAROSA OIL (UNII: 0J3G3O53ST)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    HELICHRYSUM ITALICUM FLOWER OIL (UNII: O97ZV7726K)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57520-1111-133 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/13/2012
    Labeler - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture
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