LUBRICATING EYE- mineral oil and petrolatum ointment

Lubricating Eye by

Drug Labeling and Warnings

Lubricating Eye by is a Otc medication manufactured, distributed, or labeled by Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Mineral oil (20%)
White petrolatum (80%)

PURPOSE

Eye lubricant

USES

As a lubricant to prevent further irritation or to relieve dryness of the eye(s).

WARNINGS

For use in the eyes only.

WHEN USING THIS PRODUCT

• do not touch tip of container to any surface to avoid contamination.
• replace cap after use.

STOP USE AND ASK A DOCTOR IF

• you experience eye pain, changes in vision, continued redness or irritation of the eye.
• the condition worsens or persists for more than 72 hours.

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

• Pull down the lower lid of the affected eye(s).
• Apply a small amount (1/4 inch) of ointment to the inside of the eyelid.

OTHER INFORMATION

• Do not use if carton tamper seals are broken or missing.
• Store between 15°-30°C (59°-86°F).
• Keep this carton for full product information.

SPL UNCLASSIFIED SECTION

Manufactured by :

Galentic Pharma (India) Pvt. Ltd.,

Plot No. 5 - B & 5 -C, Sector lll

Kandla Special Economic Zone,

Gandhidham - 370230, Gujarat

PRINCIPAL DISPLAY PANEL - 5 g Tube Carton

Galentic Lubricating Eye Ointment

Lubricating Eye Ointment

For Severe Dry Eyes

Sterile

Net wt. 5 g

Carton label

INGREDIENTS AND APPEARANCE

LUBRICATING EYE 
mineral oil and petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50382-017
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	200 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	800 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50382-017-01	1 in 1 CARTON	09/02/2013
1		5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/02/2013

Labeler - Galentic Pharma (India) Private Limited (915110464)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Private Limited		650970176	analysis(50382-017) , manufacture(50382-017) , pack(50382-017) , repack(50382-017) , sterilize(50382-017)