Drug Facts - Rohto Optic Glow

Drug Facts - Rohto Optic Glow
SPL v7
SPL
SPL Set ID df9c5f7c-96e6-4b2b-b8cb-21a6a3342dff
Route
OPHTHALMIC
Published
Effective Date 2022-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Naphazoline (0.3 mg) Povidone, Unspecified (5 mg) Propylene Glycol (2 mg)
Inactive Ingredients
Anhydrous Citric Acid Boric Acid Chlorobutanol Edetate Disodium Menthol, Unspecified Form Polysorbate 80 Potassium Aspartate Water Pyridoxine Hydrochloride Sodium Borate Sodium Citrate, Unspecified Form Hyaluronate Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-03-26

Description

Naphazoline hydrochloride 0.03% Povidone 0.5% Propylene glycol 0.2%

Purpose

Naphazoline hydrochloride - Redness reliever Povidone – Lubricant Propylene glycol - Lubricant


Medication Information

Purpose

Naphazoline hydrochloride - Redness reliever

Povidone – Lubricant

Propylene glycol - Lubricant

Description

Naphazoline hydrochloride 0.03% Povidone 0.5% Propylene glycol 0.2%

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

Directions
  • put 1 or 2 drops in the affected eye(s) up to 4 times daily
  • tightly snap on cap to seal
Questions?

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

Active Ingredients

Naphazoline hydrochloride 0.03%

Povidone 0.5%

Propylene glycol 0.2%

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

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
Other Safety Information
  • do not store above 25°C (77°F)
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.

Ask A Doctor Before Use If You Have

narrow angle glaucoma

Package/label Principal Display Panel

Structured Label Content

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

Naphazoline hydrochloride - Redness reliever

Povidone – Lubricant

Propylene glycol - Lubricant

Warnings

For external use only

Directions
  • put 1 or 2 drops in the affected eye(s) up to 4 times daily
  • tightly snap on cap to seal
Questions?

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

Active Ingredients (Active ingredients)

Naphazoline hydrochloride 0.03%

Povidone 0.5%

Propylene glycol 0.2%

Inactive Ingredients (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

When Using This Product (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
Other Safety Information
  • do not store above 25°C (77°F)
Stop Use and Ask A Doctor If (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. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

narrow angle glaucoma

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

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