Label: BLADDER CONTROL- calc fluor, equisetum arv, nat phos, nat sulphuricum, pulsatilla spray

  • 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 November 10, 2015

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  • PRINCIPAL DISPLAY PANEL

    Bladder Control Label

  • HPUS Active Ingredients

    Each dose contains equal parts of: Calc fluor 6C, Equisetum arv 3X, Nat phos 6C, Nat sulphuricum 6C, Pulsatilla 3X.

  • Uses

    *Homeopathic remedy for common incontinence, bladder strength, and urinary system support. *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

    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.

  • Directions

    Before initial use, depress pump 4-5 times or until primed. Hold close to mouth and spray directly into mouth. Use 3 times daily, as needed, or until symptoms improve. Adults: Take 3 sprays. Children 2-12: Take 2 sprays.

  • OTHER SAFETY INFORMATION

    Contains no artificial flavors or colors. No gluten added. Suitable for vegetarians. The letters HPUS indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. Tamper resistant for your protection. Use only if safety seal is intact.

  • INACTIVE INGREDIENT

    Citric acid, potassium sorbate, purified water.

  • 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

    Reduces sudden urges & leakages due to incontinence

  • INGREDIENTS AND APPEARANCE
    BLADDER CONTROL 
    calc fluor, equisetum arv, nat phos, nat sulphuricum, pulsatilla spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68703-207
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE (UNII: 70WT22SF4B) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE6 [hp_C]  in 59 mL
    EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z) (EQUISETUM ARVENSE TOP - UNII:1DP6Y6B65Z) EQUISETUM ARVENSE TOP3 [hp_X]  in 59 mL
    PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV) PULSATILLA VULGARIS3 [hp_X]  in 59 mL
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE6 [hp_C]  in 59 mL
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE6 [hp_C]  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68703-207-0259 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product02/15/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/15/2016
    Labeler - Silver Star Brands (006070379)
    Registrant - Silver Star Brands (006070379)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio617901350manufacture(68703-207) , api manufacture(68703-207)
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