Label: HI-DROPS- naphazoline hydrochloride and glycerin 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 January 12, 2021

If you are a consumer or patient please visit this version.

View All Sections
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

  • PURPOSE

    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 phone number provided below
  • Inactive ingredients

    Benzalkonium Chloride, Boric Acid, Edetate Disodium, Purified Water, Sodium Borate.

  • Questions?

    1-800-658-7271

  • SPL UNCLASSIFIED SECTION

    Distributed by Tiki Talk LLC/Hi-Drops
    848 N. Sunrise Blvd. Building B
    Camano Island, WA 98282

  • PRINCIPAL DISPLAY PANEL - 7 mL Bottle Blister Pack

    POCKET
    SIZE

    MAXIMUM
    REDNESS RELIEF

    HI–DROPS

    ✓RELIEVES ✓PROTECTS

    ✓SOOTHES ✓MOISTURIZES

    Made in the U.S.A.

    7 mL (0.24 fl oz)

    THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN

    STERILE EYE DROPS

    Principal Display Panel - 7 mL Bottle Blister Pack
  • INGREDIENTS AND APPEARANCE
    HI-DROPS 
    naphazoline hydrochloride and glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72254-123
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV) Naphazoline Hydrochloride0.1 mg  in 1 mL
    Glycerin (UNII: PDC6A3C0OX) (Glycerin - UNII:PDC6A3C0OX) Glycerin2.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7)  
    Boric Acid (UNII: R57ZHV85D4)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Water (UNII: 059QF0KO0R)  
    Sodium Borate (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72254-123-011 in 1 BLISTER PACK01/24/2019
    17 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart34901/24/2019
    Labeler - Tiki Talk LLC/Hi-Drops (081083951)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!