Label: BHI ACNE- silver nitrate, arnica montana, atropa belladonna, bryonia alba root, solanum dulcamara top, echinacea purpurea, calcium sulfide, lachesis muta venom, phytolacca americana root, pulsatilla vulgaris, rancid beef, toxicodendron pubescens leaf, and thuja occidentalis leafy twig 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 December 19, 2017

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    Each tablet contains: Argentum nitricum 8X,*Arnica montana, radix 6X, *Belladonna 4X, *Bryonia alba 5X, *Dulcamara 6X, *Echinacea purpurea 2X, Hepar sulphuris calcareum 10X, *Lachesis mutus 12X, *Phytolacca decandra 6X, *Pulsatilla 6X, *Pyrogenium 12X, *Rhus toxicodendron 6X, *Thuja occidentalis 6X 23.1 mg each.

    *Natural Ingredients

  • INACTIVE INGREDIENTS

    Lactose, Magnesium stearate

  • USES

    Uses: For the temporary relief of minor acne symptoms: redness, pain, and tenderness

  • WARNINGS

    Warnings: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If symptoms persist or worsen, a health professional should be consulted. Do not use if known sensitivity to Acne or any of its ingredients exists.

    Tamper Evident: Use this product only if imprinted shrink seal around neck and cap is intact.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • DIRECTIONS

    Directions: At first sign of symptoms: Adults and children 12 years and older:1 tablet every 1/2 to 1 hour until symptoms lessen, then continue with standard dosage. Do not exceed 12 tablets in 24 hours.

    Standard dosage: Adults and children 12 years and older: 3 tablets per day, taking 1 tablet every 4 to 6 hours.

    For children under 12, consult your health professional.

    Allow tablets to dissolve completely in the mouth, do not swallow.

  • USES

    Acne Relief Tablets

    Relieves:

    • Redness

    • Pain

    • Tenderness

  • PRINCIPAL DISPLAY PANEL

    BHI Acne.jpg

  • INGREDIENTS AND APPEARANCE
    BHI ACNE 
    silver nitrate, arnica montana, atropa belladonna, bryonia alba root, solanum dulcamara top, echinacea purpurea, calcium sulfide, lachesis muta venom, phytolacca americana root, pulsatilla vulgaris, rancid beef, toxicodendron pubescens leaf, and thuja occidentalis leafy twig tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62795-1013
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SILVER NITRATE (UNII: 95IT3W8JZE) (SILVER CATION - UNII:57N7B0K90A) SILVER NITRATE8 [hp_X]
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA8 [hp_X]
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA4 [hp_X]
    BRYONIA ALBA ROOT (UNII: T7J046YI2B) (BRYONIA ALBA ROOT - UNII:T7J046YI2B) BRYONIA ALBA ROOT5 [hp_X]
    SOLANUM DULCAMARA TOP (UNII: KPS1B1162N) (SOLANUM DULCAMARA TOP - UNII:KPS1B1162N) SOLANUM DULCAMARA TOP6 [hp_X]
    ECHINACEA PURPUREA (UNII: QI7G114Y98) (ECHINACEA PURPUREA - UNII:QI7G114Y98) ECHINACEA PURPUREA2 [hp_X]
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE10 [hp_X]
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM12 [hp_X]
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT6 [hp_X]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_X]
    RANCID BEEF (UNII: 29SUH5R3HU) (RANCID BEEF - UNII:29SUH5R3HU) RANCID BEEF12 [hp_X]
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF6 [hp_X]
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG6 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize9mm
    FlavorImprint Code Leafman
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62795-1013-2100 in 1 BOTTLE; Type 0: Not a Combination Product09/30/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/30/2014
    Labeler - MediNatura (079324099)
    Establishment
    NameAddressID/FEIBusiness Operations
    MediNatura102783016manufacture(62795-1013)