Label: SEAGATE OLIVE LEAF (baptisia tinctoria- wild indigo spray

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated January 29, 2019

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  • ACTIVE INGREDIENT

    ​Active Ingredients (HPUS*)​*The letters "HPUS" indicate that the components in the product are officially monographed in the Homeopathic Pharmacopoeia of the United States

    **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • INDICATIONS & USAGE

    ​​Uses

    • ​A homeopathic remedy for the temporary relief of colds and sinus irrations.

  • WARNINGS

    ​Warnings

    ​When using this product

    • ​Do not exceed recommended dosage.

    • This product may cause temporary discomfort such as burning, stinging,

    sneezing or an increase in nasal discharge.

    • ​The use of this container by more than one person may spread infection.

    • For your safety there is a full body seal over bottle printed "sealed for your protection."

    Do not use if seal is broken or missing.

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

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center

    right away.

  • DOSAGE & ADMINISTRATION

    ​Directions

    • ​Remove protective cap.

    • With your head held upright, insert nozzle into nostril and depress pump

    completely while breathing in through your nose.

    • When finished, wipe nozzle clean and replace cap.

    Adults and children 13 years and older • 1-3 sprays in each nostril, every 2-4 hours or as needed.

    Children 3-12 years •  Half the adult dose.

    Children under 3 • Consult healthcare professional

  • OTHER SAFETY INFORMATION

    ​Other Information

    ​​Store at room temperature. Does not require refridgeration.

  • INACTIVE INGREDIENT

    ​Inactive Ingredients

    ​​Benzalkonium chloride, olive leaf extract, purified water, sodium chloride, sodium hydroxide (for pH balance), xylitol.

  • QUESTIONS

    ​Questions?

    ​​Call 1-888-505-4283 toll-free in U.S., 24 hrs 7 days/week

    ​Contact Seagate for a free product catalog:

    ​1-888-505-GATE or visit

    ​www.SeagateProducts.com

    ​To report any serious adverse ​​event,

    call 1-888-505-4283

  • PRINCIPAL DISPLAY PANEL

    NDC: 66096-746-09

    SEAGATE OLIVE LEAF

    HOMEOPATHIC

    NASAL SPRAY

    ​Baptisia tinctoria

    (​Wild Indigo)

    1 fl. oz. Bottle Label

    1 fl. oz (30 mL)

    Box Carton Label

    FRONT:

    NDC: 66096-746-09

    SEAGATE OLIVE LEAF

    HOMEOPATHIC

    NASAL SPRAY

    Baptisia tinctoria

    (Wild Indigo)

    ​Temporary Relief of:

    • ​Difficulty Breathing

    • ​Mucous Blockage

    • ​Swelling of Mucous

    ​Membranes

    • ​Running Nose

    • ​Sinus Pressure

    ​and Congestion

    •​ Blocked Nose

    RIGHT SIDE:

    ​Strong enough for adults,

    ​gentle enough for children.

    ​Homeopathy is a natural approach to

    medicine that stimulates the body's

    ​curative responses so that the body helps to heal itself.

    ​Natural homeopathic products derived

    ​from plant sources are proving to be potent preservatives, treatments and

    stimulants of the body's natural

    immune system. This product does not

    contain any pharmaceutical drug.

    ​Established in 1981 ​Seagate produces 

    a variety of natural raw materials

    derived from their fishing and farming

    operations. These raw materials are

    the ingredients for a variety of Seagate's products that include:

    • ​Cold and Flu Remedies

    • ​Diet and Colon Cleanse

    • ​Fish Fertilizer

    • ​Healthy Heart and Circulation

    • ​Immune Support

    • ​Tea

    • ​Topical Skin Care

    • ​Vegetable and Fruit Concentrates

    1 fl. oz.

    (30 mL)

    ​Purpose

    Temporary relief for difficulty breathing, mucous blockage, swelling or mucous membranes, running or blocked nose, sinus pressure and congestion, accumulation of fluid.**

  • INGREDIENTS AND APPEARANCE
    SEAGATE OLIVE LEAF 
    baptisia tinctoria (wild indigo) spray
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66096-746
    Route of AdministrationNASAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BAPTISIA TINCTORIA ROOT (UNII: 5EF0HWI5WU) (BAPTISIA TINCTORIA ROOT - UNII:5EF0HWI5WU) BAPTISIA TINCTORIA ROOT4 [hp_X]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66096-746-0930 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/21/2019
    Labeler - OHM PHARMA INC. (030572478)
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