Label: D-ACNE- berberis aquifolium, thuja occidentalis, calendula officinalis ointment

  • 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 28, 2016

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  • DOSAGE & ADMINISTRATION

    Adults: Apply externally twice daily to properly cleaned & dried affected portion.

    Children under 18 years: As prescribed by the physician.

  • WARNINGS

    If symptons persist or worsen, a physician should be consulted. Keep out of reach of children. Do not use, if known sentivity to any of its ingredients exists. In case of emergency, contact a medical professional or posion control center immediately. For external use only. Replace cap tightly.

  • PURPOSE

    Controls Acne

    Skin Treatment

  • INACTIVE INGREDIENT

    Alcohol content, Cream base

  • ACTIVE INGREDIENT

    Berberis Aquifolium, Thuja Occidentalis, Calendula Officinalis

  • INDICATIONS & USAGE

    Treats acne, pimples, blotches, brown spots and dark discoloration of skin. Prevents suppuration.

  • PRINCIPAL DISPLAY PANEL

    DAcneCream

  • INGREDIENTS AND APPEARANCE
    D-ACNE 
    berberis aquifolium, thuja occidentalis, calendula officinalis ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69825-005
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THUJA OCCIDENTALIS ROOT (UNII: 12958C0BR3) (THUJA OCCIDENTALIS ROOT - UNII:12958C0BR3) THUJA OCCIDENTALIS ROOT1 [hp_X]  in 100 g
    MAHONIA AQUIFOLIUM ROOT (UNII: 746TB9VNDP) (MAHONIA AQUIFOLIUM ROOT - UNII:746TB9VNDP) MAHONIA AQUIFOLIUM ROOT1 [hp_X]  in 100 g
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69825-005-021 in 1 BOX03/28/2016
    1NDC:69825-005-0130 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/28/2016
    Labeler - Adven Biotech Private Limited (858029164)
    Establishment
    NameAddressID/FEIBusiness Operations
    Adven Biotech Private Limited858029164relabel(69825-005) , manufacture(69825-005) , repack(69825-005)
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