ROHTO OPTIC GLOW- naphazoline hydrochloride, povidone, propylene glycol liquid

Rohto Optic Glow by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active ingredients

Naphazoline hydrochloride 0.03%

Povidone 0.5%

Propylene glycol 0.2%

Purpose

Naphazoline hydrochloride - Redness reliever

Povidone – Lubricant

Propylene glycol - Lubricant

Uses

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

Warnings

For external use only

Ask a doctor before use if you have

narrow angle glaucoma

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
• overuse of this product may produce increased redness of the eye
• pupils may become enlarged temporarily

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 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 Safety Information

• do not store above 25°C (77°F)

Inactive ingredients

anhydrous citric acid, boric acid, chlorobutanol, edetate disodium, menthol, polysorbate 80, potassium aspartate, purified water, pyridoxine hydrochloride, sodium borate, sodium citrate, sodium hyaluronate

Questions?

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

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

ROHTO OPTIC GLOW 
naphazoline hydrochloride, povidone, propylene glycol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-8160
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.3 mg  in 1 mL
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E)	POVIDONE, UNSPECIFIED	5 mg  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
BORIC ACID (UNII: R57ZHV85D4)
CHLOROBUTANOL (UNII: HM4YQM8WRC)
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)
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-8160-1	1 in 1 CARTON	03/26/2021
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 Drug	M018	03/26/2021

Labeler - The Mentholatum Company (002105757)

Registrant - The Mentholatum Company (002105757)

Establishment
Name	Address	ID/FEI	Business Operations
Rohto-Mentholatum (Vietnam) Co. Ltd.		555347535	manufacture(10742-8160)