LUBRICATING EYE- mineral oil and petrolatum ointment
Galentic Pharma (India) Private Limited

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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Lubricating Eye Ointment

• 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.

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

LUBRICATING EYE
mineral oil and petrolatum ointment

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	09/02/2013

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

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

Revised: 11/2019

Document Id: 9851c382-0276-13d0-e053-2995a90a2357

Set id: 0b29e3bc-d7cc-4f0e-a6d0-c71f23ae50c8

Version: 2

Effective Time: 20191127

Galentic Pharma (India) Private Limited