Label: HEALTH MART REDNESS RELIEF- glycerin, naphazoline hydrochloride liquid

  • NDC Code(s): 62011-0297-1
  • Packager: Strategic Sourcing Services LLC
  • 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 October 17, 2019

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  • Active Ingredients

    Glycerin 0.25%

    Naphazoline hydrochloride 0.012%

  • Purpose

    Lubricant and redness reliever

  • Uses

    • relieves redness of the eye due to minor eye irritations
    • for use as a protectant against further irritation or to relieve dryness of the eye
    • temporarily relieves burning and irritation due to dryness of the eye
  • Warnings

    For external use only

    Do not use this product if

    • solution changes color or becomes cloudy

    Ask a doctor before use

    if you have narrow angle glaucoma

    When using this product

    • do not touch tip of container to any surface to avoid contamination
    • replace cap after using
    • overuse may cause more redness of the eye
    • pupils may become enlarged temporarily

    Stop use and ask a doctor if

    • you feel eye pain
    • changes in vision occur
    • redness or irritation of the eye lasts
    • condition worsens
    • symptoms last 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

    • Tamper Evident. Do not use this product if imprinted neckband is missing or broken.
    • store at room temperature
    • remove contact lenses before using
  • Inactive ingredients

    benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    HEALTH MART REDNESS RELIEF 
    glycerin, naphazoline hydrochloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62011-0297
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.25 g  in 100 mL
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.012 g  in 100 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:62011-0297-11 in 1 CARTON07/01/2015
    115 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34907/01/2015
    Labeler - Strategic Sourcing Services LLC (116956644)
    Registrant - KC Pharmaceuticals, Inc. (174450460)
    Establishment
    NameAddressID/FEIBusiness Operations
    KC Pharmaceuticals, Inc.174450460manufacture(62011-0297) , pack(62011-0297) , label(62011-0297)