Label: ACNE- niccolum sulphuricum, kali bromatum, zincum oxydatum, hepar sulphuris calcareum, sulphur. tablet, chewable

  • NDC Code(s): 61480-145-63
  • Packager: PLYMOUTH HEALTHCARE PRODUCTS 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 9, 2024

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

  • ACTIVE INGREDIENT

      Drug Facts
     Active ingredients (HPUS*) in each 600mg pill Purpose**
     Niccolum Sulphuricum 3X HPUS Pimples, Itching
     Kali Bromatum 1X HPUS Acne Simplex
     Zincum Oxydatum 1X HPUS Acne Treatment
     Hepar Sulphuris Calcareum 3X HPUS Eruption of Pimples
     Sulphur 1X HPUS Skin Eruptions, Inflammation

     *The letters "HPUS" indicate that these ingredients are officially monographed in the Homeopathic Pharmacopoeia of the United States. 1X and 3X are homeopathic dilutions.

  • INDICATIONS & USAGE

    Uses:For the temporary relief of Acne, Rosacea symptoms. **The claims for this product are based upon traditional homeopathic practice. They have not been reviewed by the FDA.

  • WARNINGS

    Warnings: 

    DO NOT USE

    • if you have kidney disease
    • in children under 10 years old
    • children under 50 lbs
    • if pregnant

    Ask a doctor before use if

    • you have a known sensitivity to nickel or costume jewelry
    • a known sensitivity to any ingredients in this product

    Stop use and ask a doctor if

    • skin rash appears
    • feelings of nervousness occur
    • if condition worsens or does not improve after regular use of this product

    ​If pregnant, ​​do not use.

     If breast-feeding, ask a doctor before use.

    Keep out of reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

    Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    Directions:Adults & Children 50 lbs & Up:

    Take ONCE per day as indicated on the chart below according to your weight:

    Weight                                Daily Dosage

    50 - 100 lbs ....................... (1) Pills Daily

    100 - 150 lbs ..................... (2) Pills Daily

    150 - 200 lbs ..................... (3) Pills Daily

    Over 200 lbs ...................... (4) Pills Daily

    Chew pill & allow to dissolve in the mouth for 1-2 minutes before swallowing. Do not eat or drink anything for 10 minutes after swallowing for maximum effectiveness. ​ Recommended treatment course: 2-4 weeks.Continue using as long as beneficial. Increase dosage by 50% if symptoms do not improve after 1 week.

  • OTHER SAFETY INFORMATION

    Other information: TAMPER EVIDENT

    • for your protection do not use if blister pack is broken.

  • INACTIVE INGREDIENT

    Inactive ingredients:Magnesium Stearate, Maltodextrin, Natural Blueberry Flavor, Sucrose.

  • QUESTIONS

    Questions or Comments?

    Call 800-316-9636, Monday through Friday, 9am - 5pm EST or visit www.lomalux.com.

  • OTHER SAFETY INFORMATION

    Distributed by Loma Lux Laboratories: 6521 Davis Industrial Parkway, Solon, Ohio 44139 USA

  • PURPOSE

    Relieves Acne Symptoms:

    Adult/Teen

    Back/Body

    Hormonal

    Rosacea

    Promotes Skin Health

  • SPL UNCLASSIFIED SECTION

    NATURAL active ingredients

    DERMATOLOGIST DEVELOPED

    LOMALUX

    LABORATORIES

    WE TARGET ACNE AT ITS SOURCE - FOR HEALTHY SKIN FROM WITHIN

    Just like your daily vitamin, Acne Pill is taken orally to relieve acne symptoms from the inside out. With just one daily dose, Acne Pill's active mineral ingredients help relieve Acne and Rosacea symptoms.

    ​WHEN USED REGULARLY, MAY HELP RELIEVE ACNE SYMPTOMS

    NATURE CREATED - DERMATOLOGIST PERFECTED

    We use only the finest quality ingredients in our exclusive formulation developed by our dermatologist founder to promote healthy skin from within. A perfect blend of science and nature.

    STEROID FREE

    LACTOSE FREE

    VEGAN/GLUTEN FREE

    NATURAL active ingredients

    DERMATOLOGIST DEVELOPED

    ​LOMALUX

    LABORATORIES

    ​EXCLUSIVE MINERAL TECHNOLOGY PROMOTES SKIN HEALTH

    5 Active Mineral Ingredients help relieve acne symptoms of pimples, blackheads, whiteheads, cystic lesions, papules, pustules, redness and inflammation. These inorganic minerals are all natural, earth derived.

    ​CUSTOMIZED DOSAGE ACCORDING TO YOUR WEIGHT - FOR OPTIMAL RESULTS

    DERMATOLOGIST DEVELOPED​, FOR HEALTHY SKIN FROM WITHIN

    STEROID FREE

    LACTOSE FREE

    VEGAN/GLUTEN FREE

  • PRINCIPAL DISPLAY PANEL

    NDC# 61480-145-63

    NATURAL active ingredients

    LOMALUX

    LABORATORIES

    ACNE • PILL™

    HEALTHY SKIN FROM WITHIN™

    Relieves Acne Symptoms:

    Adult/Teen

    Back/Body

    Hormonal

    Rosacea

    Promotes Skin Health

    HOMEOPATHIC ORAL MEDICATION

    DERMATOLOGIST DEVELOPED

    Non - Irritating

    Non - Drying

    1 DAILY DOSE

    Natural Berry Flavor

    60PILLS

    box labeling

  • INGREDIENTS AND APPEARANCE
    ACNE 
    niccolum sulphuricum, kali bromatum, zincum oxydatum, hepar sulphuris calcareum, sulphur. tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61480-145
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NICKEL SULFATE HEXAHYDRATE (UNII: JC9WZ4FK68) (NICKEL CATION - UNII:OIS2CXW7AM) NICKEL SULFATE HEXAHYDRATE3 [hp_X]
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE1 [hp_X]
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1 [hp_X]
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE3 [hp_X]
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR1 [hp_X]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    BLUEBERRY (UNII: 253RUG1X1A)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    Product Characteristics
    Colorwhite (off-white with green speckles) Score2 pieces
    ShapeROUNDSize11mm
    FlavorBLUEBERRYImprint Code LL
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61480-145-633 in 1 BOX05/01/2016
    120 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/01/2016
    Labeler - PLYMOUTH HEALTHCARE PRODUCTS LLC (079330314)