PURE EYES STERILE EYES- naphazoline hydrochloride and glycerin solution/ drops

Pure Eyes Sterile Eyes by

Drug Labeling and Warnings

Pure Eyes Sterile Eyes by is a Otc medication manufactured, distributed, or labeled by SAMSON PHARMACEUTICAL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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DRUG FACT

ACTIVE INGREDIENT

ACTIVE INGREDIENTS	PURPOSE
Naphazoline HCL 0.01%	Redness reliever
Glycerin 0.25%	Lubricant

Uses

• ♦ Relieve redness of the eye due to minor irritation
• ♦ Temporary relief of burning and irritation due to dryness of the eye
• ♦ Protects against further irritation

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

• ♦ Do not touch tip of container to any surface to avoid contamination
• ♦ Do not overuse as it may products increased redness of the eye
• ♦ Pupils may be come enlarged temporarily
• ♦ Remove contact lenses before using
• ♦ Replace cap after use

Stop use and ask a doctor if

• ♦ You experience eye pain, changes in vision, continued redness or irritation of the eyes
• ♦ Conditions worsens or persists for more than 72 hours

Keep put of reach of children. Id swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

Other information

• ♦ Store at 15- 30 C (59-86 F)
• ♦ Keep tightly closed
• ♦ Use before expiration date marked on the carton and bottle
• ♦ Serious side effect associated with use of the product may be reported to the phone number provided below

Inactive ingredients

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

Question?

1-888-995-9935

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Manufactured by:
Samson Pharmaceutical
Commerce, CA 90040
Made in USA

PRINCIPAL DISPLAY PANEL - 7 mL Bottle Blister Pack

POCKET SIZE

MAXIMUM
REDNESS RELIEF

Pure
Eyes®

STERILE
EYE DROPS

• ✓ Relieves
• ✓ Protects
• ✓ Soothes
• ✓ Moisturizes

Made in the U.S.A.

0.24 FL OZ (7ML)

INGREDIENTS AND APPEARANCE

PURE EYES STERILE EYES 
naphazoline hydrochloride and glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 20146-7000
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Naphazoline Hydrochloride (UNII: MZ1131787D) (Naphazoline - UNII:H231GF11BV)	Naphazoline Hydrochloride	0.1 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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 20146-7000-1	1 in 1 BLISTER PACK	01/01/2015
1		7 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part349	01/01/2015

Labeler - SAMSON PHARMACEUTICAL (088169581)

Establishment
Name	Address	ID/FEI	Business Operations
SAMSON PHARMACEUTICAL		088169581	MANUFACTURE(20146-7000)