SUNMARK REDNESS RELIEF- glycerin, naphazoline hydrochloride liquid

Sunmark Redness Relief by

Drug Labeling and Warnings

Sunmark Redness Relief by is a Otc medication manufactured, distributed, or labeled by Strategic Sourcing Services LLC, KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Glycerin 0.2%

Naphazoline hydrochloride 0.012%

Purpose

Lubricant and redness reliver

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 this product if

• solution changes color or become 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
• replace cap after using
• overuse may cause more redness of the eye
• pupils may become enlarged temporarily

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye lasts
• 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 right away.

Directions

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

Other information

• Tamper Evident. Do not use this product if imprinted neckband is missing or broken.
• store at room temperature
• remove contact lenses before using

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNMARK REDNESS RELIEF 
glycerin, naphazoline hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49348-894
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.2 g  in 100 mL
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.012 g  in 100 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: 49348-894-29	1 in 1 CARTON	10/01/2009
1		15 mL in 1 BOTTLE, PLASTIC; 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	10/01/2009

Labeler - Strategic Sourcing Services LLC (116956644)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(49348-894) , pack(49348-894) , label(49348-894)