Label: CAREONE MAXIMUM STRENGTH REDNESS RELIEF- glycerin, and naphazoline hydrochloride solution/ drops

  • Category: HUMAN OTC DRUG LABEL

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 17, 2021

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  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Glycerin 0.5%................................... Eye Lubricant

    Naphazoline HCl 0.03%....................Eye Redness reliever

  • PURPOSE

    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 use as a protectant against further irritation or dryness of the eye
  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use if solution changes color or becomes cloudy.

  • ASK DOCTOR

    Ask a doctor before use if you have narrow angle glaucoma.

  • WHEN USING

    When using this product

    • do not touch tip of container to any surface to avoid contamination
    • replace cap after each use
    • pupils may become enlarged temporarily
    • overuse may cause more eye redness
    • remove contact lenses before using
  • STOP USE

    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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

  • INDICATIONS & USAGE

    Directions

    • to open bottle, push cap down and twist counterclockwise
    • instill 1 to 2 drops in the affected eye(s) up to 4 times daily
    • children under 6 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    • store at room temperature 20-25°C (68-77°F)
  • INACTIVE INGREDIENT

    Inactive ingredients

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

  • DOSAGE & ADMINISTRATION

    Distributed by:

    FOODHOLD U.S.A., LLC

    LANDOVER, MD 20785

    Made in South Korea

  • PRINCIPAL DISPLAY PANEL

    41529

  • INGREDIENTS AND APPEARANCE
    CAREONE MAXIMUM STRENGTH REDNESS RELIEF 
    glycerin, and naphazoline hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-790
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.0025 mg  in 1 mL
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.00015 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:41520-790-151 in 1 BOX05/18/2017
    115 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 finalpart34905/18/2017
    Labeler - FOODHOLD U.S.A., LLC (809183973)
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