ROHTO OPTIC GLOW- naphazoline hydrochloride, 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 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

Carton
ROHTO OPTIC GLOW 
naphazoline hydrochloride, povidone, propylene glycol liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10742-8160
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV) NAPHAZOLINE HYDROCHLORIDE.3 mg  in 1 mL
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) (POVIDONE, UNSPECIFIED - UNII:FZ989GH94E) POVIDONE, UNSPECIFIED5 mg  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3) PROPYLENE GLYCOL2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10742-8160-11 in 1 CARTON03/26/2021
113 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34903/26/2021
Labeler - The Mentholatum Company (002105757)

Revised: 8/2022
Document Id: 021a3e8a-d586-4169-9dc8-f740c348526b
Set id: df9c5f7c-96e6-4b2b-b8cb-21a6a3342dff
Version: 5
Effective Time: 20220808
 
The Mentholatum Company