MANZANILLA SOPHIA (CHAMOMILE (MATRICARIA CHAMOMILLA L.)) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.]

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  • MANZANILLA SOPHIA (CHAMOMILE (MATRICARIA CHAMOMILLA L.)) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.]

MANZANILLA SOPHIA (CHAMOMILE (MATRICARIA CHAMOMILLA L.)) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.]
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NDC 57619-400-01
Set ID 9245ab82-e9fa-48c8-a412-a5cbc47e6033
Category HUMAN OTC DRUG LABEL
Packager LABORATORIOS SOPHIA, S.A. DE C.V.
Generic Name
Product Class
Product Number
Application Number
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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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