ROHTO  PRESERVATIVE FREE DRY AID- povidone, propylene glycol liquid 
The Mentholatum Company

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.

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Drug Facts

Active ingredient

Povidone 0.68%

Propylene glycol 0.3%

Purpose

Povidone – Lubricant

Propylene glycol - Lubricant

Uses

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

Other information

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
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)

Revised: 4/2023
Document Id: f94d3f12-ce4a-8dee-e053-6294a90aa0db
Set id: f4b1974c-2412-45f6-b79d-88b8a0bcb608
Version: 3
Effective Time: 20230414
 
The Mentholatum Company