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Lubricating Eye

Dosage form: ointment
Ingredients: Mineral Oil 200mg in 1g, PETROLATUM 800mg in 1g
Labeler: Galentic Pharma (India) Private Limited
NDC Code: 50382-017

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.

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.,

R-673, T.T.C, MIDC, Rabale,
Thane Belapur Road,
Navi Mumbai-400701.

PRINCIPAL DISPLAY PANEL - 5 g Tube Carton

Galentic

Lubricating
Eye
Ointment

Lubricating Eye
Ointment

For Severe
Dry Eyes

Sterile
Net wt. 5 g

Lubricating
Eye
Ointment

LUBRICATING EYE 
mineral oil and petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-017
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Mineral Oil (Mineral Oil) Mineral Oil200 mg  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM800 mg  in 1 g
Packaging
#Item CodePackage Description
1NDC:50382-017-011 TUBE in 1 CARTON
15 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/02/2013
Labeler - Galentic Pharma (India) Private Limited (915110464)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Private Limited864201135ANALYSIS(50382-017), MANUFACTURE(50382-017), PACK(50382-017), REPACK(50382-017), STERILIZE(50382-017)
Establishment
NameAddressID/FEIOperations
Galentic Pharma (India) Private Limited650970176ANALYSIS(50382-017), MANUFACTURE(50382-017), PACK(50382-017), REPACK(50382-017), STERILIZE(50382-017)

Revised: 12/2017
 
Galentic Pharma (India) Private Limited

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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