CLEAR EYES REDNESS RELIEF- naphazoline hydrochloride and glycerin liquid

Clear Eyes Redness Relief by

Drug Labeling and Warnings

Clear Eyes Redness Relief by is a Otc medication manufactured, distributed, or labeled by Preferred Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Clear Eyes Redness Relief

Drug Facts

Active Ingredients

Glycerin 0.25%

Purpose

Lubricant

Active Ingredients

Naphazoline hydrochloride 0.012%

Purpose

Redness Reliever

Uses

• relieves redness of the eye due to minor eye irritations
  
• for use as a protectant against further irritation or to relieve dryness of the eye
  
• for the temporary relief of burning and irritation due to dryness of the eye

Warnings

For external use only

Do not use

if solution changes color or becomes cloudy

Ask a doctor before use if 

you have narrow angle glaucoma.

When using this product:

• pupils may become enlarged temporarily
  
• overuse may produce increased redness of the eye
  
• remove contact lenses before using
  
• to avoid contamination, do not touch tip of container to any surface
  
• replace cap after using

Stop use and ask a doctor if

• you experience eye pain
  
• you experience changes in vision
  
• you experience continued redness or irritation of the eye
  
• the condition worsens
  
• symptoms last for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Instill 1 to 2 drops in the affected eye(s) up to 4 times daily.

Other Information

• store at room temperature
  
•  

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

Questions?

1-877-274-1787 www.cleareyes.com.

SPL UNCLASSIFIED SECTION

Clear Eyes Redness Relief, Handy Pocket Pal

Drug Facts

Active Ingredients

Glycerin 0.25%

Purpose

Lubricant

Active Ingredients

Naphazoline hydrochloride 0.012%

Purpose

Redness Reliever

Uses

• Relieves redness of the eye due to minor eye irritations.
  
• For use as a protectant against further irritation or to relieve dryness of the eye.
  
• Temporarily relieves burning and irritation due to dryness of the eye.

Warnings

For external use only

Do not use

if solution changes color or becomes cloudy.

Ask a doctor before use if

you have narrow angle glaucoma.

When using this product 

• To avoid contamination, do not touch tip to any surface.
  
• Replace cap after using.
  
• Overuse may cause increased redness of the eye.
  
• Pupils may become enlarged temporarily.

Stop use & ask a doctor if

• you experience eye pain
  
• you experience changes in vision
  
• you experience continued redness or irritation of the eye
  
• the condition worsens
  
• symptoms last for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center  (1-800-222-1222) right away.

Directions

Instill 1 to 2 drops in the affected eye(s) up to four times daily.

Other Information

• Store Between 20° -25°C (68° -77°F)
  
• Remove contact lenses before using.

Relabeled By: Preferred Pharmaceuticals Inc.

Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate

Questions?

1-877-274-1787 www.cleareyes.com

PRINCIPAL DISPLAY PANEL

Clear eyes REDNESS RELIEF
LUBRICANT/REDNESS RELIEVER EYE DROPS
Sterile 0.5 FL OZ (15 mL)

INGREDIENTS AND APPEARANCE

CLEAR EYES REDNESS RELIEF 
naphazoline hydrochloride and glycerin liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68788-7611(NDC:67172-797)
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.12 mg  in 1 mL
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68788-7611-1	1 in 1 BOX	02/07/2020
1		30 mL in 1 BOTTLE; 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	02/07/2020

Labeler - Preferred Pharmaceuticals Inc. (791119022)

Registrant - Preferred Pharmaceuticals Inc. (791119022)

Establishment
Name	Address	ID/FEI	Business Operations
Preferred Pharmaceuticals Inc.		791119022	RELABEL(68788-7611)