ROHTO  SUN AND SPORT- hypromellose, povidone 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

Hypromellose 0.3%

Povidone 0.5%

Purpose

Hypromellose – Lubricant

Povidone - Lubricant

Uses

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 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

alginic acid, anhydrous citric acid, boric acid, camphor, chlorobutanol, edetate disodium, menthol, polysorbate 80, purified water, sodium borate, sodium citrate, taurine, zinc sulfate

Questions?

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

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Carton
ROHTO   SUN AND SPORT
hypromellose, povidone liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8140
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO) HYPROMELLOSE, UNSPECIFIED3 mg  in 1 mL
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E) POVIDONE, UNSPECIFIED5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALGINIC ACID (UNII: 8C3Z4148WZ)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
BORIC ACID (UNII: R57ZHV85D4)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CHLOROBUTANOL (UNII: HM4YQM8WRC)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
RACEMENTHOL (UNII: YS08XHA860)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
WATER (UNII: 059QF0KO0R)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
TAURINE (UNII: 1EQV5MLY3D)  
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8140-11 in 1 CARTON07/01/2022
118 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 finalpart34907/01/2022
Labeler - The Mentholatum Company (002105757)

Revised: 4/2023
Document Id: f94d35cb-be00-88c3-e053-6294a90a51b0
Set id: 8bcc8882-b886-4b55-9bc4-d4b92a41358f
Version: 2
Effective Time: 20230414
 
The Mentholatum Company