Label: MANZANILLA SOPHIA (chamomile- matricaria chamomilla l. solution/ drops

  • NDC Code(s): 57619-400-01
  • Packager: LABORATORIOS SOPHIA, S.A. DE C.V.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated January 9, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredient

    Chamomile (Matricaria chamomilla L.) 3X HPUS

    "HPUS" indicates that this ingredient is officially monographed in the Homeopathic Pharmacopoeia of the United States.

  • PURPOSE

    Purpose

    Eye moisturizer

  • INDICATIONS & USAGE

    Use* to refresh and replenish moisture to eyes.

  • WARNINGS

    Warnings

    For external use only

    Do not use if solution changes color or becomes cloudy

    When using this product

    • do not touch tip of container to any surface to avoid contamination
    • replace cap after using

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye lasts
    • condition worsens or lasts more than 72 hours

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

  • DOSAGE & ADMINISTRATION

    Directions

    Put 2 drops into each eye as needed

  • STORAGE AND HANDLING

    Other information

    • store at room temperature.

    Do not use

    • if imprinted seal around cap is broken or missing
  • INACTIVE INGREDIENT

    Inactive ingredients Benzalkonium chloride (as preservative), sodium chloride, sodium phosphate dibasic monohydrate, sodium phosphate monobasic monohydrate, water for injection

  • QUESTIONS

    Questions?

    1-866-202-8871

    www.manzanillasophia.com

  • SPL UNCLASSIFIED SECTION

    *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

  • SPL UNCLASSIFIED SECTION

    NDC 57619-400-01

    Distributed by:

    LABS SOPHIA USA, INC.

    1790 Hughes Landing Blvd Suite 400

    The Woodlands, TX 77380

    MADE IN MEXICO

    www.sophialabs.com

  • PRINCIPAL DISPLAY PANEL

    HOMEOPATHIC

    Manzanilla Sophia™

    Chamomile

    Herbal Eye Drops

    REFRESH YOUR EYES

    Cleanses

    Soothes

    0.5 FL OZ (15 mL)

    STERILE

    Manzanilla Sophia 11-2021

  • INGREDIENTS AND APPEARANCE
    MANZANILLA  SOPHIA
    chamomile (matricaria chamomilla l.) solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57619-400
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA3 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57619-400-011 in 1 PACKAGE04/12/2010
    115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/12/2010
    Labeler - LABORATORIOS SOPHIA, S.A. DE C.V. (810143636)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABORATORIOS SOPHIA, S.A. DE C.V.810143636manufacture(57619-400)
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