RESTORATIVE FORMULA LUBRICANT EYE DROPS- propylene glycol liquid

Restorative Formula Lubricant Eye Drops by

Drug Labeling and Warnings

Restorative Formula Lubricant Eye Drops by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Daewoo Pharmaceutical Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Propylene glycol....0.6%

PURPOSE

Purpose

Propylene glycol............ Lubricant

INDICATIONS & USAGE

Uses
for the temporary relief of burning and irritation due to dryness of the eye

WARNINGS

Warnings
For external use only

Do not use
if this product changes color
if you are sensitive to any ingredient in this product

When using this product
do not touch tip of container to any surface to avoid contamination
replace cap after each use

Stop use and ask a doctor if
you experience eye pain
changes in vision occur
redness or irritation of the eye(s) gets worse, persists 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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

Directions

• Shake well before using.
• Instill 1 or 2 drops in the affected eye(s) as needed

OTHER SAFETY INFORMATION

Other information

• Store at room temperature.

INACTIVE INGREDIENT

Inactive ingredients

Benzalkonium chloride, boric acid, castor oil, disodium edetate hydrate, polyoxyethylene sorbitan monooleate, potassium chloride, purified water, sodium borate, sodium chloride.  May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

QUESTIONS

Questions & comments?

1-888-527-4276

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RESTORATIVE FORMULA LUBRICANT EYE DROPS 
propylene glycol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70000-0013
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
CASTOR OIL (UNII: D5340Y2I9G)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PEG-6 SORBITAN OLEATE (UNII: 58O7V09UCI)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70000-0013-1	1 in 1 BOX	04/30/2019
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC: 70000-0013-2	2 in 1 BOX	04/30/2019
2		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	04/30/2019

Labeler - Cardinal Health (097537435)

Registrant - Daewoo Pharmaceutical Co., Ltd. (689046329)

Establishment
Name	Address	ID/FEI	Business Operations
Daewoo Pharmaceutical Co., Ltd.		689046329	manufacture(70000-0013) , pack(70000-0013) , label(70000-0013)