Label: ANCIENT SECRETS BREATHE AGAIN- sodium chloride aerosol, 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 October 30, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium Chloride 2.0% (Seawater-derived)

  • Purpose

    Restores Moisture

  • Uses

    for nasal rinsing in adults:

    • Moisturizes and cleanses nasal passages due to pollution, dry air, air conditioning, dust, pollen
    • Nasal drainage
    • Helps dry congestion due to colds and allergies
  • Warnings

    For nasal use only.

    When using this product

    • To avoid contamination, do not touch tip of the dispenser to any surface.
    • Do not use the same dispenser on different people.

    Stop use and ask a doctor if you experience any discomfort while using this product.

    Keep out of the reach of children.

  • Directions

    • Tilt head to one side and forward.
      Holding can parallel to the nose, insert nozzle into upper nostril.
    • Press valve briefly for release of fine mist.
      Repeat 2-3 times on each nostril as needed.
    • Use 2-4 times daily, or as often as necessary.
    • Use with children ages 6 and older.
    • Wash carefully with clean warm water and dry carefully after each use.
  • Other Information

    • Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate.
    • Store at room temperature (59-86°F).
  • Inactive Ingredients

    purified water

  • Questions, Comments, Side Effects?

    Call toll free 800-824-6396, Monday – Friday, 9:00 – 5:00, CST

  • SPL UNCLASSIFIED SECTION

    Manufactured by
    Gerolymatos International S.A.
    Athens, Greece

    ®©2011, Distributed by Lotus Brands, Inc.,
    A majority woman-owned family business
    1100 Lotus Drive, Silver Lake, WI 53170, USA

  • PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

    ANCIENT
    SECRETS    ®

    Breathe
    Again™

    Hypertonic Seawater
    Nasal Spray

    • Sterilized
    • Helps Dry Congestion
      Due to Colds and Allergies
    • Preservative-Free Saline

    3.38 fl.oz. (100 mL)

    Principal Display Panel - 100 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    ANCIENT SECRETS   BREATHE AGAIN
    sodium chloride aerosol, spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76328-100
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Sodium Chloride (UNII: 451W47IQ8X) (Sodium Cation - UNII:LYR4M0NH37) Sodium Chloride20 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76328-100-001 in 1 CARTON08/15/2011
    1100 mL in 1 CANISTER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34908/15/2011
    Labeler - LOTUS BRANDS, INC. (879022713)
    Establishment
    NameAddressID/FEIBusiness Operations
    GEROLYMATOS INTERNATIONAL SA506173753MANUFACTURE(76328-100)
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