STERILUBE - petrolatum ophthalmic ointment 
Fera Pharmaceuticals

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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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


STERILUBE BOX LABEL

Nighttime Relief

FERA PHARMACEUTICALS

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


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

CF01235

STERILUBE 
petrolatum ophthalmic ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:48102-012
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM850 g  in 1 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL150 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48102-012-351 in 1 CARTON02/01/201006/14/2013
13.5 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/01/201006/14/2013
Labeler - Fera Pharmaceuticals (831023713)
Registrant - Fera Pharmaceuticals (831023713)

Revised: 1/2010
Document Id: 9315c8bf-e5f0-468a-9603-feb6ba685ecb
Set id: 1135b995-2110-499d-ae70-840637703932
Version: 2
Effective Time: 20100122
 
Fera Pharmaceuticals