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

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 April 14, 2023

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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 finalpart34906/03/2022
    Labeler - The Mentholatum Company (002105757)
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