Seagate Olive Leaf

Seagate Olive Leaf
SPL v1
SPL
SPL Set ID cd959b0a-0ca2-48a0-a4ba-984ac4c130f6
Route
NASAL
Published
Effective Date 2019-01-29
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Baptisia Tinctoria Root (4 [hp_X])
Inactive Ingredients
Benzalkonium Chloride Olea Europaea Leaf Water Sodium Hydroxide Sodium Chloride Xylitol

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-01-21

Description

​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.


Medication Information

Warnings and Precautions

​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.

Indications and Usage

​Uses

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

Dosage and 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

Description

​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.

Section 50565-1

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

right away.

Section 51727-6

​Inactive Ingredients

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

Section 51945-4

NDC: 66096-746-09

SEAGATE OLIVE LEAF

HOMEOPATHIC

NASAL SPRAY

​Baptisia tinctoria

( ​Wild Indigo)

1 fl. oz (30 mL)

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)

Section 53413-1

​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

Section 55105-1

​Purpose

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

Section 55106-9

​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.

Section 60561-8

​Other Information

​Store at room temperature. Does not require refridgeration.


Structured Label Content

Indications and Usage (34067-9)

​Uses

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

Dosage and Administration (34068-7)

​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

Warnings and Precautions (34071-1)

​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.

Section 50565-1 (50565-1)

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

right away.

Section 51727-6 (51727-6)

​Inactive Ingredients

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

Section 51945-4 (51945-4)

NDC: 66096-746-09

SEAGATE OLIVE LEAF

HOMEOPATHIC

NASAL SPRAY

​Baptisia tinctoria

( ​Wild Indigo)

1 fl. oz (30 mL)

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)

Section 53413-1 (53413-1)

​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

Section 55105-1 (55105-1)

​Purpose

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

Section 55106-9 (55106-9)

​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.

Section 60561-8 (60561-8)

​Other Information

​Store at room temperature. Does not require refridgeration.


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