DG LUBRICANT EYE DROPS- polyethylene glycol 400 solution

DG LUBRICANT EYE DROPS by

Drug Labeling and Warnings

DG LUBRICANT EYE DROPS by is a Otc medication manufactured, distributed, or labeled by HANLIM PHARM. CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                                             Purpose

Polyethylene Glycol 400 (0.4%).........................................Lubricant

Propylene Glycol (0.3%)...................................................Lubricant

PURPOSE

Uses

• For the temporary relief of burning and irritation due to dryness of the eyes.
• For protection against further irritation.
  

WARNINGS

Warnings   For external use only

DO NOT USE

Do not use

• if this product changes color or becomes cloudy.
• if you are sensitive to any ingredient in this product.
  

WHEN USING

When using this product

• Do not touch tip of container to any surface to avoid contamination.
• Replace cap after each use.
  

STOP USE

Stop use and ask a doctor if

• you feel eye pain.
• changes in vision occur.
• redness or irritation of the eye(s) gets worse 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.

INDICATIONS & USAGE

Directions

• Instill 1 to 2 drops in the affected eye(s) as needed
• Children under 6 years of age: Ask a doctor
  

SAFE HANDLING WARNING

Other Information

• Store at room temperature.
• Do not use if carton is open or neckband on the bottle is broken or missing.
  

INACTIVE INGREDIENT

Inactive Ingredients: Boric Acid, Calcium Chloride, Chlorhexidine Gluconate, Hydrochloric Acid, Hypromellose 2910, Magnesium Chloride, Potassium Chloride, Purified Water, Sodium Chloride, Sodium Hydroxide, Zinc Chloride

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

DG LUBRICANT EYE DROPS 
polyethylene glycol 400 solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11716-0051
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL - UNII:3WJQ0SDW1A)	POLYETHYLENE GLYCOL 400	0.4 mL  in 1 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.3 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E)
HYDROCHLORIC ACID (UNII: QTT17582CB)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11716-0051-7	1 in 1 CARTON
1		15 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	04/26/2010

Labeler - HANLIM PHARM. CO., LTD. (687986034)