Label: HEB EYE DROPS- glycerin, naphazoline hydrochloride liquid

  • 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 27, 2023

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  • Active ingredients

    Glycerin 0.5%

    Naphazoline hydrochloride 0.03%

  • Purpose

    Lubricant

    Redness reliever

  • Uses

    • for the relief of redness of the eye due to minor eye irritations.
    • for the temporary relief of burning and irritation due to the dryness of the eye.
    • for the use as a protectant against further irritation or dryness of the eye
  • 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

    When using this product

    • To avoid contamination, do not touch tip of container to any surface.
    • Replace cap after using.
    • Overuse may produce increased redness of the eye
    • Pupils may become enlarged temporarily.

    Stop use and ask a doctor if

    • you experience eye pain
    • you experience changes in vision
    • you experience 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 or 2 drops in the affected eye(s) up to 4 times daily.
  • Other information

    Store at room temperature.

  • Inactive ingredients

    benzalkonium chloride, boric acid, disodium edetate hydrate, sodium borate, water for injection

  • Package label

    carton

  • package label

    carton

  • INGREDIENTS AND APPEARANCE
    HEB EYE DROPS 
    glycerin, naphazoline hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-560
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.12 mg  in 15 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN2.5 mg  in 15 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BORIC ACID (UNII: R57ZHV85D4)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37808-560-022 in 1 BOX12/11/2020
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:37808-560-011 in 1 BOX12/11/2020
    215 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 finalpart34912/11/2020
    Labeler - H E B (007924756)
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