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

  • NDC Code(s): 10742-8162-1, 10742-8162-2
  • 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 7, 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
    • replace cap after each use
    • do not use if solution changes color or becomes cloudy

    Stop use and ask a doctor if

    • you feel 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) as needed
    • tightly snap on cap to seal

    Other information

    • do not freeze
  • Inactive ingredients

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

  • Questions?

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

  • Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    ROHTO DRY-AID 
    povidone, propylene glycol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8162
    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)  
    POLIHEXANIDE HYDROCHLORIDE (UNII: 4XI6112496)  
    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:10742-8162-11 in 1 CARTON01/01/2017
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:10742-8162-22 in 1 CARTON01/01/2017
    210 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 finalpart34901/01/2017
    Labeler - The Mentholatum Company (002105757)
    Registrant - The Mentholatum Company (002105757)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rohto Pharmaceutical Co. Ltd.696604024manufacture(10742-8162)
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