- DRUG FACTS
- Active Ingredients
- Purpose
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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
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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.
- Direction:
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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:
- SPL UNCLASSIFIED SECTION
- Packaging
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INGREDIENTS AND APPEARANCE
LUTESOL HOMEOPATHIC MEDICINE STERILE EYE DROPS
calendula officinalis solution/ dropsProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72709-821 Route of Administration OPHTHALMIC Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP 3 [hp_X] in 15 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) BORIC ACID (UNII: R57ZHV85D4) CALCIUM CHLORIDE (UNII: M4I0D6VV5M) HYDROCHLORIC ACID (UNII: QTT17582CB) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) MAGNESIUM CHLORIDE (UNII: 02F3473H9O) POTASSIUM CHLORIDE (UNII: 660YQ98I10) WATER (UNII: 059QF0KO0R) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM HYDROXIDE (UNII: 55X04QC32I) ZINC CHLORIDE (UNII: 86Q357L16B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72709-821-78 1 in 1 BOX 11/28/2018 1 15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/28/2018 Labeler - Yokina Inc. (075411878)