Lubricating Eye (Mineral Oil And Petrolatum) Ointment [Galentic Pharma (India) Private Limited] -

LUBRICATING EYE (MINERAL OIL AND PETROLATUM) OINTMENT [GALENTIC PHARMA (INDIA) PRIVATE LIMITED]
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NDC	50382-017-01
Set ID	0b29e3bc-d7cc-4f0e-a6d0-c71f23ae50c8
Category	HUMAN OTC DRUG LABEL
Packager	Galentic Pharma (India) Private Limited
Generic Name
Product Class
Product Number
Application Number	PART347

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• 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

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)

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Medic