Label: OPTIC SPLASH- naphazoline hydrochloride, glycerin solution/ drops

  • NDC Code(s): 49873-501-01
  • Packager: Sato Pharmaceutical, Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 4, 2023

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  • ACTIVE INGREDIENT

    Active ingredients
    Glycerin 0.2%
    Naphazoline hydrochloride 0.02%

  • PURPOSE

    Purpose
    Glycerin     Lubricant
    Naphazoline hydrochloride     Redness reliever

  • INDICATIONS & USAGE

    Uses
    ■ Relieves redness of the eye due to minor eye irritations.
    ■ Temporarily relieves burning and irritation due to dryness of the eye.

  • WARNINGS

    Warnings
    For external use only

    Do not use

    ■ if solution changes color or becomes cloudy

    A sk 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 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

    ■ 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.

  • DOSAGE & ADMINISTRATION

    Directions
    Instill 1 to 2 drops in the affected eye(s) up to four times daily.

  • OTHER SAFETY INFORMATION

    Other information
    ■ store tightly closed, protected from light.

  • INACTIVE INGREDIENT

    Inactive ingredients
    benzalkonium chloride, boric acid, camphor, menthol, polysorbate 80, potassium chloride, purified water, sodium borate, sodium chloride

  • PRINCIPAL DISPLAY PANEL

    opticsplashcart.jpg carton

  • INGREDIENTS AND APPEARANCE
    OPTIC SPLASH 
    naphazoline hydrochloride, glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-501
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE20 mg  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN200 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49873-501-011 in 1 CARTON01/22/2008
    115 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01801/22/2008
    Labeler - Sato Pharmaceutical, Co., Ltd. (690575642)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sato Pharmaceutical, Co. Ltd.715699133manufacture(49873-501) , label(49873-501) , pack(49873-501)
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