Label: HYD- glycerin and naphazoline hydrochloride solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 12, 2018

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Glycerin 0.25%Lubricant
    Naphazoline HCL 0.012%Redness reliever
  • Uses

    • relieves redness of the eye due to minor eye irritations
    • temporary relief of burning and irritation due to dryness of the eyes
    • protects against further irritation
  • Warnings

    For external use only.

    Do not use if solution changes color or becomes cloudy

    Ask a doctor before use if you have

    • narrow angle glaucoma
    • high blood pressure
    • diabetes
    • any eye injuries or infection

    When using this product

    • do not touch tip container to any surface to avoid contamination
    • do not overuse as it may produce increased redness of the eye pupils may become enlarged temporarily
    • remove contact lenses before using
    • replace cap after use

    Stop use and ask a doctor if

    • you experience eye pain, changes in vision, continued redness or irritation of the eye
    • condition worsens or persists for more than 72 hours

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

  • Directions

    • instill 1 to 2 drops in the affected eye(s) up to four times daily
  • Other information

    • store at 15°-30° C (59°-86°F)
    • keep tightly closed
    • use before expiration date marked on the carton and bottle
    • serious side effects associated with use of product may be reported to the URL provided below
  • Inactive ingredients

    Purified Water, Boric Acid, Disodium EDTA, Sodium Borate, Benzalkonium Chloride

  • Questions?

    www.HYDyourHIGH.com

  • PRINCIPAL DISPLAY PANEL - 7 mL Bottle Blister Pack

    HYD
    YOUR
    HIGH

    HYD
    hydyourhigh.com

    PREMIUM
    EYE
    DROPS

    Redness Relief
    Soothing
    Moisturizing
    Discreet

    STERILE
    0.24 fl oz (7mL)

    CRAFTED FOR THE CANNABIS CULTURE | MADE IN THE U.S.A.

    Principal Display Panel - 7 mL Bottle Blister Pack
  • INGREDIENTS AND APPEARANCE
    HYD 
    glycerin and naphazoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72632-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin2.5 mg  in 1 mL
    Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV) Naphazoline Hydrochloride0.12 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Boric Acid (UNII: R57ZHV85D4)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    Sodium Borate (UNII: 91MBZ8H3QO)  
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72632-001-011 in 1 BLISTER PACK11/14/2018
    17 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34911/14/2018
    Labeler - HyConcepts (111960216)
    Establishment
    NameAddressID/FEIBusiness Operations
    Samson Pharmaceuticals Inc.088169581MANUFACTURE(72632-001)
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