Drug Labeling and Warnings

Drug Details [pdf]

EYE DROPS REDNESS AND DRY EYE RELIEF- naphazoline hydrochloride, glycerin solution/ drops 
Strategic Sourcing Services LLC

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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Active ingredients

Glycerin 0.2 %

Naphazoline hydrochloride 0.012%

Purpose

Glycerin ....Lubricant

Naphazoline hydrochloride ....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 this product 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
• 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

EYE DROPS REDNESS AND DRY EYE RELIEF 
naphazoline hydrochloride, glycerin solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62011-0100
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	2 mg  in 1 mL
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.12 mg  in 1 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62011-0100-1	1 in 1 CARTON	03/01/2012	02/28/2018
1		15 mL in 1 BOTTLE, DROPPER; 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	03/01/2012	02/28/2018

Labeler - Strategic Sourcing Services LLC (116956644)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(62011-0100) , pack(62011-0100) , label(62011-0100)

Revised: 10/2019

Document Id: 94842f75-5061-747e-e053-2a95a90ace57

34390-5

Set id: ff0b8b3f-f1c0-4758-a632-d6e44d8e6dbb

Version: 2

Effective Time: 20191009