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STERILUBE OINTMENT

Dosage form: ointment
Ingredients: PETROLATUM 850g in 1g, MINERAL OIL 150mg in 1g
Labeler: Fera Pharmaceuticals
NDC Code: 48102-012

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.

DRUG FACTS

Active ingredients

Mineral Oil 15% and White Petrolatum 85%

Purpose

Eye Lubricant

Uses
  • as a lubricant to prevent further irritation
  • to relieve dryness of the eye(s).

Warnings
  • For use in the eyes only.
  • Save box for complete information.

When using this product
  • avoid contamination, do not touch tip of container to any surface.
  • replace cap after using.

Stop use and ask a doctor if
  • you experience eye pain, changes in vision, continued redness or irritation of the eye.
  • condition worsens or persists for more than 72 hours.

Keep this and all drugs out of the reach of children.

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

Directions
  • pull down lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid.

Other Information
  • store at room temperature 15o-30oC (59o-86oF).
  • protect from freezing.
  • see crimp of tube or box for lot number and expiration date.
  • keep tightly closed.

Questions and comments?
  • (414) 434-6604
  • 9 AM - 5 PM EST Monday - Friday

PRINCIPAL DISPLAY PANEL

Nighttime Relief

STERILUBE

OINTMENT

PETROLATUM OPHTHALMIC OINTMENT

STERILE OCULAR LUBRICANT

  • preservative free
  • relieves dryness
  • prevents further irritation
Use as a lubricant to prevent further irritation or to relieve dryness of the eye.

STERILUBE

OINTMENT

PETROLATUM OPHTHALMIC OINTMENT

STERILE OCULAR LUBRICANT

Net Wt. 1/8 oz. (3.5 g)

DO NOT USE IF BOTTOM RIDGE OF TUBE CAP IS EXPOSED AND IMPRINTED SEAL ON SIDE FLAPS IS NOT INTACT.
Manufactured for


Fera Pharmaceuticals, LLC.  Locust Valley N.Y.  11560

CF01235
STERILUBE OINTMENT 
petrolatum ophthalmic ointment ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48102-012
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (PETROLATUM) PETROLATUM850 g  in 1 g
MINERAL OIL (MINERAL OIL) MINERAL OIL150 mg  in 1 g
Packaging
#Item CodePackage Description
1NDC:48102-012-351 TUBE (TUBE) in 1 CARTON
13.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/01/2010
Labeler - Fera Pharmaceuticals (831023713)
Registrant - Fera Pharmaceuticals (831023713)

Revised: 01/2010
Document Id: 5cea83a1-652c-44c3-90cf-37556026bfa3
Set id: 1135b995-2110-499d-ae70-840637703932
Version: 1
Effective Time: 20100122
 
Fera Pharmaceuticals

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 drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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