SALINE MIST SPRAY [REBEL DISTRIBUTORS CORP]

SALINE MIST SPRAY [REBEL DISTRIBUTORS CORP]
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NDC 21695-353-45
Set ID d37b05cd-155b-4ac6-9892-7c82d2f65b5f
Category HUMAN OTC DRUG LABEL
Packager Rebel Distributors Corp
Generic Name
Product Class
Product Number
Application Number PART349
  • Active ingredient

    Sodium Chloride 0.65%

  • PURPOSE

  • Keep Out of Reach of Children

  • Uses

    For dry nasal membranes squeeze twice in each nostril as needed.

    Upright delivers a spray; Horizontally a stream; Upside down a drop.

  • Warnings

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

  • Directions

    For dry nasal membranes squeeze twice in each nostril as needed.

  • Inactive ingredients

    Purified Water, sodium chloride 0.65%, Disodium Phosphate, Phenylcarbinol, Monosodium Phosphate, Benzalkonium Chloride

  • Package/Label Principal Display Panel

    Saline Mist 0.65%

  • INGREDIENTS AND APPEARANCE
    SALINE MIST 
    saline mist spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-353(NDC:45802-357)
    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
    WATER (UNII: 059QF0KO0R)  
    SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM PHOSPHATE, MONOBASIC ANHYDROUS (UNII: KH7I04HPUU)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-353-4545 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34904/24/2009
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK

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