Label: DR MINERAL NASAL SPRAY- sodium chloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 28, 2010

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  • PURPOSE

    [Uses]
    Dr. Mineral Nasal Spray is useful as a nasal wash for stuffy nose, allergies and colds: relieving dry and inflamed membranes.  Moisturizes nasal passages
  • WHEN USING

    [Directions]
    Remove the cap first.  Push down the nozzle 2-3 times with fingers in each nostril.  Adults and children 4 years to under 12 years of age (with adult supervision): Apply up to 5 times daily to obtain the desired results.  Children under 4 years: ask a doctor
  • WARNINGS

    [Warnings]
    - The use of this dispenser by more than one person may spread infection
    - Avoid spraying in eyes
    - Do not exceed recommended dosage
    - If pregnant or breast-feeding, ask a health professional before use
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children
  • ACTIVE INGREDIENT

    [Ingredients} Water, Sodium Chloride 0.65%, Glycerin
  • STORAGE AND HANDLING

    [Storage]
    Store at a room temperature
  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL LABEL
  • INGREDIENTS AND APPEARANCE
    DR MINERAL NASAL SPRAY 
    sodium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50499-100
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE0.39 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 59.31 mL  in 60 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.3 mL  in 60 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50499-100-6060 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/31/2010
    Labeler - MineralBio (631154981)
    Registrant - MineralBio (631154981)
    Establishment
    NameAddressID/FEIBusiness Operations
    MineralBio631154981manufacture
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