Label: SALINE WASH- sodium bicarbonate, sodium chloride powder, for solution

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated May 22, 2013

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  • INACTIVE INGREDIENT

    Inactive Ingredients

    None

  • ACTIVE INGREDIENT

    Active Ingredients

    (in each packet)

    Sodium Bicarbonate USP 700 mg

    Sodium Chloride USP 1200 mg


  • WARNINGS

    Warnings

    For external use only

  • PURPOSE

    Purpose

    Nasal wash

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach from children

  • INDICATIONS & USAGE

    Uses

    Temporarily relieves symptoms associated with sinusitis, colds, flu or allergies

    Sneezing

    Runny nose

    Nasal stuffiness

    Post nasal drip

    Removes inhaled irritants (dust, pollen)

    Promotes nasal and sinus drainage

    Helps reduce swelling of nasal membranes

  • DOSAGE & ADMINISTRATION

    Directions

    Adults and children 4 years and over: 1-2 packets every 2 hours as needed

    Children under 4 years: Consult a doctor

    Consult Instructions for Use for proper use

  • OTHER SAFETY INFORMATION

    Other Information

    Inspect saline solution packets for integrity

    Do not use if open or torn

    Protect saline solution packets from excessive heat and moisture

  • PRINCIPAL DISPLAY PANEL

    copy of label

  • INGREDIENTS AND APPEARANCE
    SALINE WASH 
    sodium bicarbonate, sodium chloride powder, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-408
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE700 mg
    SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20) SODIUM BICARBONATE2300 mg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-408-00100 in 1 CARTON
    11 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other04/01/2013
    Labeler - Target Corporation (006961700)