Label: HOMEOPATHIC ACNE FORMULA- arsenicum album, nitricum acidum, hepar sulfuris calcarea, eugenia jambosa, aurum metallicum, calcarea suflruica, solidago virgaurea, hydrastis canadensis tablet

  • 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 25, 2011

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  • ACTIVE INGREDIENT

    I n g r e d i e n t s :
    Rose apple ........................ 3C HPUS
    Goldenrod ..................... 3C HPUS
    Goldenseal ................. 3C HPUS
    Arsenic trioxide ....................... 4C HPUS
    Nitric acid ........................ 4C HPUS
    Calcium sulfate ................... 5C HPUS
    Calcium sulfide ......... 6C HPUS
    Gold (metallic) ..................... 6C HPUS

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

  • PURPOSE

    Reduces the
    occurrence of non-cystic
    acne and pimples.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF
    REACH OF CHILDREN.

  • INDICATIONS & USAGE

    Reduces the
    occurrence of non-cystic
    acne and pimples.

  • WARNINGS

    Warning: If you are taking any medications or
    are pregnant or breast feeding do not use prior to
    consulting a physician.

  • DOSAGE & ADMINISTRATION


    Suggested Use: Adults and children over 12
    years, take 1-2 tablets, dissolve under tongue or
    chew 2 times daily until symptoms appear to
    reduce, or as directed by a health professional. If
    symptoms persist for more than 10 days consult a
    health professional.
  • INACTIVE INGREDIENT

    Inactive Ingredients: Dextrose, Magnesium
    Stearate, Silica.

  • PRINCIPAL DISPLAY PANEL

    NDC# 1057802590

    Homeopathic
    Acne
    Reduces the
    occurrence of non-cystic
    acne and pimples.
    300 mg.
    90 Tablets



    image of label

  • USER SAFETY WARNINGS

    For your protection, this container has an outer
    safety seal. (Do not accept if missing or broken.)
    Best if used by date on bottle. Store in a dry cool place.
    Any Questions? 1-800-644-8327
    website: www.botanicchoice.com

  • SPL UNCLASSIFIED SECTION

    FDA Establishment #: 1811575

    Distributed by: Indiana Botanic Gardens, Inc.
    3401 W. 37th Ave. Hobart, IN 46342

  • INGREDIENTS AND APPEARANCE
    HOMEOPATHIC ACNE FORMULA 
    arsenicum album, nitricum acidum, hepar sulfuris calcarea, eugenia jambosa, aurum metallicum, calcarea suflruica, solidago virgaurea, hydrastis canadensis tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10578-025
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC TRIOXIDE - UNII:S7V92P67HO) ARSENIC TRIOXIDE4 [hp_C]
    NITRIC ACID (UNII: 411VRN1TV4) (NITRIC ACID - UNII:411VRN1TV4) NITRIC ACID4 [hp_C]
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFIDE6 [hp_C]
    SYZYGIUM JAMBOS SEED (UNII: 97P0H45869) (SYZYGIUM JAMBOS SEED - UNII:97P0H45869) SYZYGIUM JAMBOS SEED3 [hp_C]
    GOLD (UNII: 79Y1949PYO) (GOLD - UNII:79Y1949PYO) GOLD6 [hp_C]
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (SULFATE ION - UNII:7IS9N8KPMG) CALCIUM SULFATE ANHYDROUS5 [hp_C]
    SOLIDAGO VIRGAUREA FLOWERING TOP (UNII: 5405K23S50) (SOLIDAGO VIRGAUREA FLOWERING TOP - UNII:5405K23S50) SOLIDAGO VIRGAUREA FLOWERING TOP3 [hp_C]
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL3 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    DEXTROSE (UNII: IY9XDZ35W2)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize3mm
    FlavorImprint Code H;367
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10578-025-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2003
    Labeler - Indiana Botanic Gardens (005421771)
    Registrant - Indiana Botanic Gardens (005421771)
    Establishment
    NameAddressID/FEIBusiness Operations
    Indiana Botanic Gardens005421771label
    Establishment
    NameAddressID/FEIBusiness Operations
    ASI Marketing Group964366611manufacture
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