CALCAREA FLOUR GEL [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]

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CALCAREA FLOUR GEL [RXHOMEO PRIVATE LIMITED D.B.A. RXHOMEO, INC]
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NDC 15631-2309-0, 15631-2309-1, 15631-2309-2, 15631-2309-3
Set ID ba6a4aa5-a060-40c8-a7b2-1f6fa45b2ff6
Category HUMAN OTC DRUG LABEL
Packager Rxhomeo Private Limited d.b.a. Rxhomeo, Inc
Generic Name
Product Class
Product Number
Application Number
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  • ACTIVE INGREDIENT

    CALCAREA FLOUR GEL 3X HPUS

  • USES

    Varicose veins, fissures, cracks and lumbago.

  • INDICATIONS

    Condition listed above or as directed by the physician

  • DOSAGE & ADMINISTRATION SECTION

    Apply a thin layer of Gel to the affected area, repeat 3 times a day or as needed.

  • WARNINGS

    This product is to be used for self-limiting conditions

    If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

    As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product

    Keep this and all medication out of reach of children

    Do not use if capseal is broken or missing.
    Close the cap tightly after use.

  • INACTIVE INGREDIENTS

    ALOE VERA GEL

  • STORAGE

    Store in a cool dark place

  • QUESTIONS OR COMMENTS

    www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com

    Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CALCAREA FLOUR 
    calcarea flour gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15631-2309
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM FLUORIDE (UNII: O3B55K4YKI) (FLUORIDE ION - UNII:Q80VPU408O) CALCIUM FLUORIDE3 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15631-2309-01 in 1 CONTAINER03/30/2016
    150 g in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:15631-2309-11 in 1 CONTAINER03/30/2016
    2100 g in 1 CONTAINER; Type 0: Not a Combination Product
    3NDC:15631-2309-21 in 1 CONTAINER03/30/2016
    3200 g in 1 CONTAINER; Type 0: Not a Combination Product
    4NDC:15631-2309-31 in 1 CONTAINER03/30/2016
    4500 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/30/2016
    Labeler - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc (650833994)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rxhomeo Private Limited d.b.a. Rxhomeo, Inc650833994manufacture(15631-2309) , label(15631-2309)
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