Label: FAMILY CARE SALINE- sodium chloride spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 2, 2024

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  • ACTIVE INGREDIENT

    Active ingredient Purpose

    Sodium Chloride 0.65%......................Moisturizer

  • PURPOSE

    Use

    temporary relief of dry, irritated nasal passages due to colds, flu, allergies, pollution, and the use of decongestants/steroidal sprays

  • WARNINGS

    Warnings

    For external use only

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • holding bottle upright for spray, horizontally for stream, and upside down for drop applications
    • adults and children under 6 years of age: squeeze twice in each nostril as needed
    • children under 6 years of age: consult a doctor
    • using this dispenser by more than one person may spread infection
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
    • do not use if printed seal around the cap is broken or missing
  • INACTIVE INGREDIENT

    Inactive ingredients

    benzalkonium chloride, benzyl alcohol, purified water, sodium phosphate dibasic anhydrous, sodium phosphate monobasic monohydrate

  • DOSAGE & ADMINISTRATION

    Distributed by: United Exchange Corp.

    Cypress, CA 90630 USA

    Made in China

  • PRINCIPAL DISPLAY PANEL

    493

  • INGREDIENTS AND APPEARANCE
    FAMILY CARE SALINE 
    sodium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65923-493
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE6.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65923-493-4444 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/28/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01209/28/2023
    Labeler - United Exchange Corp. (840130579)
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