Label: ACNE RELIEF- saponaria, echinacea angustifolia, kalium bromatum, viola tricolor, selenium metallicum, nux vomica, thuja occidentalis, pulsatilla, calcarea picrata, sulphur iodatum, antimonium tartaricum pellet

  • 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 October 18, 2013

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  • ACTIVE INGREDIENTS HPUS

    Saponaria officinalis 3X

    Echinacea angustifolia 3X

    Kalium bromatum 6X

    Viola tricolor 3X

    Selenium metallicum 4C

    Nux vomica 6C

    Thuja occidentalis 6C

    Pulsatilla 6C

    Calcarea picrata 6C

    Sulphur iodatum 6C

    Antimonium tartaricum 6C

  • REFERENCES

    Manufactured according to the Homeopathic Pharmacopoeia of the United States (HPUS)

  • PURPOSE

    Helps Relieve Symptoms due to Acne

  • USES

    This is a natural Homeopathic remedy that helps relieve Acne

  • WARNINGS

  • ASK DOCTOR

    If symptoms persist or worsen, discontinue use and contact a health professional.

  • PREGNANCY OR BREAST FEEDING

    As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medications out of reach of children.

  • DIRECTIONS

    Adults: Allow 3 or 4 pellets to dissolve in mouth three times a day for 2 months.  

    Children under 12: Take 1/2 the adult dose. Do not exceed the recommended dosage.

  • OTHER INFORMATION

    Do not use if cap seal is broken.

  • DESCRIPTION

    Homeolab USA Inc., 3025 de L'Assomption Blvd., Montreal, QC H1N 2H2   Canada

    PRODUCT OF CANADA

  • CARTON

    IMAGE OF CARTONIMAGE OF LABEL

  • INGREDIENTS AND APPEARANCE
    ACNE RELIEF 
    saponaria, echinacea angustifolia, kalium bromatum, viola tricolor, selenium metallicum, nux vomica, thuja occidentalis, pulsatilla, calcarea picrata, sulphur iodatum, antimonium tartaricum pellet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60512-0007
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SAPONARIA OFFICINALIS ROOT (UNII: RI2K1BMA8B) (SAPONARIA OFFICINALIS ROOT - UNII:RI2K1BMA8B) SAPONARIA OFFICINALIS ROOT3 [hp_X]
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA3 [hp_X]
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE6 [hp_X]
    VIOLA TRICOLOR (UNII: 9Q24RAI43V) (VIOLA TRICOLOR - UNII:9Q24RAI43V) VIOLA TRICOLOR3 [hp_X]
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM4 [hp_C]
    STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED6 [hp_C]
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG6 [hp_C]
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS6 [hp_C]
    CALCIUM PICRATE (UNII: 53D441QVT8) (CALCIUM PICRATE - UNII:53D441QVT8) CALCIUM PICRATE6 [hp_C]
    SULFUR IODIDE (UNII: L6L8KA2AA0) (SULFUR IODIDE - UNII:L6L8KA2AA0) SULFUR IODIDE6 [hp_C]
    ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    SUCROSE (UNII: C151H8M554)  
    LACTOSE (UNII: J2B2A4N98G)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeROUNDSize4mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60512-0007-180 in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/18/2013
    Labeler - HOMEOLAB USA INC. (202032533)
    Establishment
    NameAddressID/FEIBusiness Operations
    HOMEOLAB USA INC.202032533manufacture(60512-0007)
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