ROHTO DUAL LIGHT RELIEF- hypromellose, povidone liquid

Rohto by

Drug Labeling and Warnings

Rohto by is a Otc medication manufactured, distributed, or labeled by Rohto Pharmaceutical Co., Ltd., The Mentholatum Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Hypromellose 0.3%

Povidone 0.5%

Purpose

Hypromellose – Lubricant

Povidone - Lubricant

Uses

• for the temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
• 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 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

• put 1 or 2 drops in the affected eye(s) as needed
• tightly snap on cap to seal
  

Other information

• do not store above 25 OC (77 OF)

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)

PRINCIPAL DISPLAY PANEL

Principal Display Panel

INGREDIENTS AND APPEARANCE

ROHTO  DUAL LIGHT RELIEF
hypromellose, povidone liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66613-8459
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	5 mg  in 1 mL
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO)	HYPROMELLOSE, UNSPECIFIED	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CHLOROBUTANOL (UNII: HM4YQM8WRC)
WATER (UNII: 059QF0KO0R)
TAURINE (UNII: 1EQV5MLY3D)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
BORIC ACID (UNII: R57ZHV85D4)
ZINC SULFATE HEPTAHYDRATE (UNII: N57JI2K7WP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
LEVOMENTHOL (UNII: BZ1R15MTK7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALGINIC ACID (UNII: 8C3Z4148WZ)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66613-8459-1	1 in 1 CARTON	05/30/2024
1		18 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	05/30/2024

Labeler - Rohto Pharmaceutical Co., Ltd. (690573662)

Registrant - The Mentholatum Company (002105757)

Establishment
Name	Address	ID/FEI	Business Operations
The Mentholatum Company		002105757	label(66613-8459)

Establishment
Name	Address	ID/FEI	Business Operations
Rohto Pharmaceutical Co., Ltd.		696604024	manufacture(66613-8459)