ROHTO DIGI-EYE- hypromellose, tetrahydrozoline hydrochloride liquid

Rohto Digi-Eye by

Drug Labeling and Warnings

Rohto Digi-Eye by is a Otc medication manufactured, distributed, or labeled by The Mentholatum Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Hypromellose 0.35%

Tetrahydrozoline hydrochloride 0.05%

Purpose

Hypromellose - Lubricant

Tetrahydrozoline hydrochloride - Redness reliever

Uses

• temporarily relieves burning and irritation due to dryness of the eye
• relieves redness of the eye due to minor eye irritations

Warnings

For external use only

Ask a doctor before use if you have

narrow angle glaucoma

When using this produce

• 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
• overuse may cause more eye redness
• pupils may become enlarged temporarily
• remove contact lenses before using

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) up to 4 times daily
• tightly snap on cap to seal

Other information

• do not store above at 25°C (77°F)

Inactive ingredients

benzalkonium chloride, boric acid, chlorobutanol, cyanocobalamin, edetate disodium, menthol, polysorbate 80, potassium aspartate, purified water, pyridoxine hydrochloride, sodium borate

Questions or comments?

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

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

ROHTO DIGI-EYE 
hypromellose, tetrahydrozoline hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-8175
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO)	HYPROMELLOSE, UNSPECIFIED	3.5 mg  in 1 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
CHLOROBUTANOL (UNII: HM4YQM8WRC)
CYANOCOBALAMIN (UNII: P6YC3EG204)
EDETATE DISODIUM (UNII: 7FLD91C86K)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM ASPARTATE (UNII: OC4598NZEQ)
WATER (UNII: 059QF0KO0R)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-8175-1	1 in 1 CARTON	03/01/2018
1		13 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	03/01/2018

Labeler - The Mentholatum Company (002105757)