Label: ROHTO OPTIC GLOW- naphazoline hydrochloride, povidone, propylene glycol liquid

  • NDC Code(s): 10742-8160-1
  • Packager: The Mentholatum Company
  • 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 February 8, 2023

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  • Active ingredients

    Naphazoline hydrochloride 0.03%

    Povidone 0.5%

    Propylene glycol 0.2%

  • Purpose

    Naphazoline hydrochloride - Redness reliever

    Povidone – Lubricant

    Propylene glycol - Lubricant

  • Uses

    • relieves redness of the eye due to minor eye irritations
    • temporarily relieves burning and irritation due to dryness of the eye
  • Warnings

    For external use only

    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 each use
    • do not use if solution changes color or becomes cloudy
    • overuse of this product may produce increased redness of the eye
    • pupils may become enlarged temporarily

    Stop use and ask a doctor if

    • you experience eye pain
    • changes in vision occur
    • redness or irritation of the eyes lasts
    • condition worsens or lasts more than 72 hours

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • put 1 or 2 drops in the affected eye(s) up to 4 times daily
    • tightly snap on cap to seal

    Other Safety Information

    • do not store above 25°C (77°F)
  • Inactive ingredients

    anhydrous citric acid, boric acid, chlorobutanol, edetate disodium, menthol, polysorbate 80, potassium aspartate, purified water, pyridoxine hydrochloride, sodium borate, sodium citrate, sodium hyaluronate

  • Questions?

    1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

  • Package/Label Principal Display Panel

    Carton
  • INGREDIENTS AND APPEARANCE
    ROHTO OPTIC GLOW 
    naphazoline hydrochloride, povidone, propylene glycol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8160
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE0.3 mg  in 1 mL
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E) POVIDONE, UNSPECIFIED5 mg  in 1 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CHLOROBUTANOL (UNII: HM4YQM8WRC)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM ASPARTATE (UNII: OC4598NZEQ)  
    WATER (UNII: 059QF0KO0R)  
    PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8160-11 in 1 CARTON03/26/2021
    113 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34903/26/2021
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rohto-Mentholatum (Vietnam) Co. Ltd.555347535manufacture(10742-8160)
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