Label: DR MINERAL ANTI-ITCH- 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 February 20, 2010

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  • PURPOSE

    [Uses]
    Dr. Mineral Anti-Itch Spray is useful for the temporary relief of itching associated with irritation, rashes and inflammation due to
    - skin dryness - eczema - psoriasis - photo sensitivity - jewelry - insect bites - soaps and detergents - cosmetics - poison ivy, oak or sumac - seborrheic dermattis - Other use of this product ask a doctor
  • WHEN USING

    [Directions]
    Apply when needed not more than 5-6 times a day.
    - spray 2-3 times when use
    - Children under 2 years, do not use: ask a doctor
  • WARNINGS

    [Warnings] For external use only.
    - Do not use in or near the eyes.  For diaper rash: ask a doctor
    - Stop use and ask a doctor if
          - condition worsens
          - symtoms persist for more than 7 days or clear up and occur again within a few days
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children.  If swallowed, get medical help or contact a Poison Control Center immediately.
  • ACTIVE INGREDIENT

    [Active Ingredients} Sodium Chloride 0.7%, Menthol 0.05%
  • STORAGE AND HANDLING

    [Storage]
    Store at a room temperature.  Protect from freezing and excessive heat.
    Expire: 02.25.2012
  • PRINCIPAL DISPLAY PANEL

    PRINCIPAL LABEL
  • INACTIVE INGREDIENT

    [Inactive Ingredients] Water, Glycerin, Grapefruit Seed Extract, Zinc Chloride, Cupric Chloride, Germanium Dioxide, Ethanol, Polysorbate 20

  • INGREDIENTS AND APPEARANCE
    DR MINERAL ANTI-ITCH 
    sodium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50499-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE0.7 mL  in 100 mL
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.05 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 98 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 0.5 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50499-300-10100 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34902/20/2010
    Labeler - MineralBio (631154981)
    Registrant - MineralBio (631154981)
    Establishment
    NameAddressID/FEIBusiness Operations
    MineralBio631154981manufacture
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