Lutesol homeopathic Medicine Sterile Eye Drops

Lutesol homeopathic Medicine Sterile Eye Drops
SPL v1
SPL
SPL Set ID ee90e4bf-38d5-43cb-9203-e659626724bc
Route
OPHTHALMIC
Published
Effective Date 2018-12-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (3 [hp_X])
Inactive Ingredients
Polyethylene Glycol 400 Propylene Glycol Benzalkonium Chloride Boric Acid Calcium Chloride Hydrochloric Acid Hypromellose, Unspecified Magnesium Chloride Potassium Chloride Water Sodium Chloride Sodium Hydroxide Zinc Chloride

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-11-28

Description

Calendula Officinalis (Marigold containing Lutein), HPUS 3x, 6x, 12x "HPUS" indicates the active ingredients of this product are officially monographed in the Homeopathic Pharmacopoeia of the United States

Purpose

Corneal health


Medication Information

Purpose

Corneal health

Description

Calendula Officinalis (Marigold containing Lutein), HPUS 3x, 6x, 12x "HPUS" indicates the active ingredients of this product are officially monographed in the Homeopathic Pharmacopoeia of the United States

Uses*

According to homeopathic indications these ingredients provide temporary relief from symptoms such as Dryness, redness and promote corneal health, after a serious causes have been ruled out by physician.

*These statements are based on traditional homeopathic practice. They have not been reviewed by Food and Drug Administration

Section 42229-5

Supports:

Corneal Health

Healthy Vision

Dry Eyes

Made In USA

U.S. Distributor:

Yokina Inc.

Rancho cucamonga,

CA 91730

Section 50565-1

• Keep out of reach of children • In case of accidental ingestion, get medical help or contact a poison control center right away

Warnings

For external use only.

• This product is intended to complement, not replace standard medical treatment • Suitable for adults and children ages 12 and over. • Initial worsening of symptoms may occur • If pregnant or breast-feeding, ask a health professional before use • Contact lens wearers: Consult a physician before use • Replace cap after every use • Expiration date only refers to the unopened bottle. • The use of this container to more than one person may spread infection

Do not use if : • Solution changes color or becomes cloudy • You feel eye pain or changes in vision, continued redness, or the irritation of the eye • The condition get worse • redness or irritation of the eye(s) get worse, persists or last longer than 72 hours.

Packaging

Drug Facts

Direction:

• Shake well before using

• Instill 1-3 drops in the affected eye(s). Use several times per day as needed.

• Homeopathic remedies may not be effective for everyone.

• Individual results may vary.

Active Ingredients

Calendula Officinalis (Marigold containing Lutein), HPUS 3x, 6x, 12x

"HPUS" indicates the active ingredients of this product are officially monographed in the Homeopathic Pharmacopoeia of the United States

Other Information:

• There are known contraindications

• Active ingredients are micro-diluted in accordance with Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects.

• Store at room temperature

• Do not touch tip of container to any surface to avoid contamination

• Keep bottle tightly closed

Inactive Ingredient:

Polyethylene Glycol, Propylene glycol, Benzalkonium chloride, Boric acid, Calcium chloride, Hydrochloric acid, Hypromellose, Magnesium chloride, Potassium chloride, Purified water, Sodium chloride, Sodium hydroxide, Zinc chloride


Structured Label Content

Uses*

According to homeopathic indications these ingredients provide temporary relief from symptoms such as Dryness, redness and promote corneal health, after a serious causes have been ruled out by physician.

*These statements are based on traditional homeopathic practice. They have not been reviewed by Food and Drug Administration

Section 42229-5 (42229-5)

Supports:

Corneal Health

Healthy Vision

Dry Eyes

Made In USA

U.S. Distributor:

Yokina Inc.

Rancho cucamonga,

CA 91730

Section 50565-1 (50565-1)

• Keep out of reach of children • In case of accidental ingestion, get medical help or contact a poison control center right away

Purpose

Corneal health

Warnings

For external use only.

• This product is intended to complement, not replace standard medical treatment • Suitable for adults and children ages 12 and over. • Initial worsening of symptoms may occur • If pregnant or breast-feeding, ask a health professional before use • Contact lens wearers: Consult a physician before use • Replace cap after every use • Expiration date only refers to the unopened bottle. • The use of this container to more than one person may spread infection

Do not use if : • Solution changes color or becomes cloudy • You feel eye pain or changes in vision, continued redness, or the irritation of the eye • The condition get worse • redness or irritation of the eye(s) get worse, persists or last longer than 72 hours.

Packaging

Drug Facts (DRUG FACTS)

Direction:

• Shake well before using

• Instill 1-3 drops in the affected eye(s). Use several times per day as needed.

• Homeopathic remedies may not be effective for everyone.

• Individual results may vary.

Active Ingredients

Calendula Officinalis (Marigold containing Lutein), HPUS 3x, 6x, 12x

"HPUS" indicates the active ingredients of this product are officially monographed in the Homeopathic Pharmacopoeia of the United States

Other Information: (Other information:)

• There are known contraindications

• Active ingredients are micro-diluted in accordance with Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects.

• Store at room temperature

• Do not touch tip of container to any surface to avoid contamination

• Keep bottle tightly closed

Inactive Ingredient: (Inactive ingredient:)

Polyethylene Glycol, Propylene glycol, Benzalkonium chloride, Boric acid, Calcium chloride, Hydrochloric acid, Hypromellose, Magnesium chloride, Potassium chloride, Purified water, Sodium chloride, Sodium hydroxide, Zinc chloride


Advanced Ingredient Data


Raw Label Data

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