Label: FAMILY CARE PREMIUM SALINE NASAL- sodium chloride solution

  • Category: HUMAN OTC DRUG LABEL

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 June 2, 2014

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  • ACTIVE INGREDIENT

    Active Ingredient                                         Purpose

    Sodium chloride 0.65%................................Moisturizer

  • PURPOSE

    Uses

    • For dry nasal membranes
  • WARNINGS

    Warnings

    For external use only

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

  • DO NOT USE

    The use of this dispenser by more than one person may spread infection

  • INDICATIONS & USAGE

    Directions

    • squeeze twice in each nostril as needed
    • upright delivers a spray, horizontally a stream, upside down a drop
  • INACTIVE INGREDIENT

    Inactive Ingredeints

    Benzalkonium chloride, dibasic sodium phosphate, monobasic sodium, phosphate, purified water, sorbitol solution

  • DOSAGE & ADMINISTRATION

    Distributed by:

    United Exchange Corp.

    17211 Valley View Ave.

    Cerritos, CA 90703 USA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE PREMIUM SALINE NASAL  
    sodium chloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-557
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE0.29 mg  in 44 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-557-4444 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34906/02/2014
    Labeler - United Exchange Corp (840130579)
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