Label: ROHTO PRESERVATIVE FREE DRY AID- povidone, propylene glycol liquid

  • NDC Code(s): 10742-8161-1
  • Packager: The Mentholatum Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 17, 2024

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  • Active ingredient

    Povidone 0.68%

    Propylene glycol 0.3%

  • Purpose

    Povidone – Lubricant

    Propylene glycol - Lubricant

  • Uses

    • temporarily relieves burning and irritation due to dryness of the eye
    • protects against further irritation or to relieve dryness of the eye
  • Warnings

    For external use only

    When using this product

    • do not touch tip of container to any surface to avoid contamination
    • do not reuse
    • once opened, discard
    • do not use if solution changes color or becomes cloudy

    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 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

    • twist tab completely to remove; do not pull tab off
    • instill 1 or 2 drops in the affected eye(s) as needed
    • discard container

    Other information

    • use only if single-use container is intact
    • do not freeze
  • Inactive ingredients

    boric acid, calcium chloride, edetate disodium, magnesium sulfate, menthol, PEG-10 castor oil, poloxamer, polyoxyl stearate, purified water, sesame oil, sodium borate

  • Questions?

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

  • Principal Display Panel

    Carton
  • INGREDIENTS AND APPEARANCE
    ROHTO  PRESERVATIVE FREE DRY AID
    povidone, propylene glycol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8161
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E) POVIDONE, UNSPECIFIED6.8 mg  in 1 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORIC ACID (UNII: R57ZHV85D4)  
    CALCIUM CHLORIDE (UNII: M4I0D6VV5M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
    RACEMENTHOL (UNII: YS08XHA860)  
    POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
    PEG/PPG-105/5 COPOLYMER (UNII: 52901V8XAR)  
    POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)  
    WATER (UNII: 059QF0KO0R)  
    SESAME OIL (UNII: QX10HYY4QV)  
    SODIUM BORATE (UNII: 91MBZ8H3QO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10742-8161-130 in 1 CARTON06/03/2022
    10.5 mL in 1 VIAL, SINGLE-USE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01806/03/2022
    Labeler - The Mentholatum Company (002105757)
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