Lutesol Homeopathic Medicine Sterile Eye Drops
FDA Label NDC 72709-821
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yokina Inc. for the product Lutesol Homeopathic Medicine Sterile Eye Drops (NDC 72709-821). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredients, purpose, uses*, warnings, otc - keep out of reach of children, direction:, other information:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
Purpose
Corneal health
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
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.
Otc - Keep Out Of Reach Of Children
• Keep out of reach of children • In case of accidental ingestion, get medical help or contact a poison control center right away
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.
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
Packaging
Lutesol-1 (Lutesol Nw)
* Please review the disclaimer below.
