Label: CALGONATE CALCIUM GLUCONATE GEL 2.5%- calcium gluconate gel

  • NDC Code(s): 0295-7520-40
  • Packager: Denison Pharmaceuticals, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 26, 2019

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  • ACTIVE INGREDIENT

    Active ingredients

    Calcium Gluconate, 2.5%

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of Reach of Children. For external use only. Avoid contact with eyes.

  • PURPOSE

    Purpose

    First aid response to hydrofluorix acid (HF) exposure

  • DOSAGE & ADMINISTRATION

    Directions

    Before applying gel, rinse area with water. Invert cap and pierce metal seal to open tube. Apply gel freely, massage in. Reapply gel every 10 to 15 minutes while seeking emergency medical assistance.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Purified water, Cabapol 934 Polymer, Methylparaben, Sodium Hydroxide

  • INDICATIONS & USAGE

    Intended Use:

    Topical skin treatment for hydrofuoric acid burns or exposure.

  • WARNINGS

    Warnings

    Do not use if tube is damaged or open.

    Re-use risks: contamination, low product efficacy.

  • PRINCIPAL DISPLAY PANEL

    cartoninsert

  • INGREDIENTS AND APPEARANCE
    CALGONATE CALCIUM GLUCONATE GEL  2.5%
    calcium gluconate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0295-7520
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM GLUCONATE (UNII: SQE6VB453K) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM GLUCONATE2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 934 (UNII: Z135WT9208)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-7520-4025 g in 1 BOTTLE; Type 0: Not a Combination Product03/26/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/26/2019
    Labeler - Denison Pharmaceuticals, LLC (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(0295-7520)
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