Label: WELL-EX- arsenicum alb, graphites, hepar sulph calc, radium brom, viola tric 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 4, 2023

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  • HPUS Active Ingredients

    HPUS Active Ingredients: Equal volumes of each ingredient: Arsenicum alb 6C, Graphites 6C, Hepar sulph calc 6C, Radium brom 30C, Viola tric 6C.

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

  • Uses*

    Uses*: Soothes transient itching and weeping of skin during an eczema 'flare up'.

    *This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

  • Warnings

    Warnings: If symptoms persist or worsen, consult a healthcare professional. If pregnant or breastfeeding, ask a health professional before use. Keep this and all medication out of reach of children. In case of oversdose, get medical help or contact a Poison Control Center right away.

  • Directions

    Directions: Chew or dissolve tablets in the mouth. Alternatively, crush and sprinkle directly on the tongue or mix in warm water or soft food. Use 3 times daily, 30 minutes before food, until symptoms subside. Adults & children 13+: 2 tablets. Childeren 2-12: 1 tablet.

  • OTHER SAFETY INFORMATION

    Contains no artificial flavors or colorants. No gluten added.

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

  • Inactive Ingredients

    Inactive Ingredients: Acacia gum, distilled water, lactose, magnesium stearate, sucrose.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all medication out of reach of children.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • PURPOSE

    Soothes symptoms of transient skin flare-ups in children with eczema or atopic dermatitis.

  • PRINCIPAL DISPLAY PANEL

    Well-Ex

  • INGREDIENTS AND APPEARANCE
    WELL-EX 
    arsenicum alb, graphites, hepar sulph calc, radium brom, viola tric tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-318
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE6 [hp_C]
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE6 [hp_C]
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE6 [hp_C]
    RADIUM BROMIDE (UNII: R74O7T8569) (RADIUM CATION - UNII:05456MVL7T) RADIUM BROMIDE30 [hp_C]
    VIOLA TRICOLOR (UNII: 9Q24RAI43V) (VIOLA TRICOLOR - UNII:9Q24RAI43V) VIOLA TRICOLOR6 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA (UNII: 5C5403N26O)  
    WATER (UNII: 059QF0KO0R)  
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    Colorwhite (Round Lactose Tablets) Scoreno score
    ShapeROUND (Round White Lactose Tablets) Size6mm
    FlavorImprint Code None
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-318-30180 in 1 BOTTLE, GLASS; Type 0: Not a Combination Product12/17/2018
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/17/2018
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (003070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    KingBio617901350manufacture(68703-318)
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