LUTESOL HOMEOPATHIC MEDICINE STERILE EYE DROPS (CALENDULA OFFICINALIS) SOLUTION/ DROPS [ YOKINA INC. ]

LUTESOL HOMEOPATHIC MEDICINE STERILE EYE DROPS (CALENDULA OFFICINALIS) SOLUTION/ DROPS [ YOKINA INC. ]
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NDC 72709-821-78
Set ID ee90e4bf-38d5-43cb-9203-e659626724bc
Category HUMAN OTC DRUG LABEL
Packager Yokina Inc.
Generic Name
Product Class
Product Number
Application Number
  • DRUG FACTS

  • 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.

    • 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

  • SPL UNCLASSIFIED SECTION

    Supports:

    Corneal Health

    Healthy Vision

    Dry Eyes

    Made In USA

    U.S. Distributor:

    Yokina Inc.

    Rancho cucamonga,

    CA 91730

  • Packaging

    Lutesol-1

  • INGREDIENTS AND APPEARANCE
    LUTESOL HOMEOPATHIC MEDICINE STERILE EYE DROPS 
    calendula officinalis solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72709-821
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72709-821-781 in 1 BOX11/28/2018
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/28/2018
    Labeler -  Yokina Inc. (075411878)

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