Label: ACNE CLEAR- antimonium tartaricum, asterias rubens, ferrum metallicum, hepar sulphuris calcareum, kali bromatum, natrum muriaticum, sanguinaria canadensis, selenium metallicum, sepia, silicea, sulphur, thuja occidentalis liquid

  • 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 20, 2014

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  • DOSAGE & ADMINISTRATION

    Directions: Before initial dose depress pump 4-5 times or until primed and spray 1 dose directly in mouth 4 to 6 times daily until symptoms improve.

    Adult Dose: 3 Pump Sprays

    Child's Dose (2-12): 2 Pump Sprays

    Infants - 2 yrs: 1 Pump Spray

  • WARNINGS

    Warnings: If symptoms persist or worsen, seek advice of a physician. If pregnant or breast-feeding, take only on advice of physician.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OTHER SAFETY INFORMATION

    Other information: Tamper resistant for your protection. Use only if safety seal is intact.

  • PURPOSE

    Indications: For temporary relief of: •acne •oily skin •blackheads •pimples •earthy complextion •unhealthy skin

    Associated with: •adolescence •menstruation •menopause •middle-age

  • ACTIVE INGREDIENT

    Active Ingredients: Antimonium tartaricum, Asterias rubens, Ferrum metallicum, Hepar sulphuris calcareum, Kali bromatum, Natrum muriaticum, Sanguinaria canadensis, Selenium metallicum, Sepia, Silicea, Sulphur, Thuja occidentalis. ​Equal volumes of each ingredient in 10X, 30X, 100X potencies.

  • INACTIVE INGREDIENT

    Inactive Ingredient: Citric acid, potassium sorbate, purified water.

  • INDICATIONS & USAGE

    Indications: For temporary relief of:

    • acne
    • oily skin
    • blackheads
    • pimples
    • earthy complextion
    • unhealthy skin
    Associated with:
    • adolescence
    • menstruation
    • menopause
    • middle-age
  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ACNE CLEAR 
    antimonium tartaricum, asterias rubens, ferrum metallicum, hepar sulphuris calcareum, kali bromatum, natrum muriaticum, sanguinaria canadensis, selenium metallicum, sepia, silicea, sulphur, thuja occidentalis liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66579-0010
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANTIMONY POTASSIUM TARTRATE (UNII: DL6OZ476V3) (ANTIMONY CATION (3+) - UNII:069647RPT5) ANTIMONY POTASSIUM TARTRATE10 [hp_X]  in 59 mL
    ASTERIAS RUBENS (UNII: A7FYY9Q742) (ASTERIAS RUBENS - UNII:A7FYY9Q742) ASTERIAS RUBENS10 [hp_X]  in 59 mL
    IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON10 [hp_X]  in 59 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE10 [hp_X]  in 59 mL
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE10 [hp_X]  in 59 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE10 [hp_X]  in 59 mL
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508) (SANGUINARIA CANADENSIS ROOT - UNII:N9288CD508) SANGUINARIA CANADENSIS ROOT10 [hp_X]  in 59 mL
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM10 [hp_X]  in 59 mL
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE10 [hp_X]  in 59 mL
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (COLLOIDAL SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE10 [hp_X]  in 59 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR10 [hp_X]  in 59 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG10 [hp_X]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66579-0010-259 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/21/2010
    Labeler - New Sun Inc. (957251176)
    Registrant - New Sun Inc. (957251176)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(66579-0010)
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