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Puralube

Fera Pharmaceuticals

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Mineral Oil (150mg) 15% and White Petrolatum (850mg) 85%

Purpose

Eye Lubricant

Puralube 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.

Puralube Other information

  • store at 20º - 25ºC (68º - 77ºF) [See USP Controlled Room Temperature].
  • 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

PURALUBE OINTMENT

PETROLATUM OPHTHALMIC OINTMENT
STERILE OCULAR LUBRICANT

DESCRIPTION: A sterile ocular emollient (lubricant).

Contains: Mineral Oil 15% and White Petrolatum 85%.

INDICATIONS: For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

DIRECTIONS: Pull down the lower eyelid of the affected eye(s) and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid, one or more times daily, or as directed by a doctor.

WARNINGS: To avoid contamination of this product do not touch the tip of the container to any surface. Replace cap after using. If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

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

DO NOT USE IF BOTTOM RIDGE OF TUBE CAP IS EXPOSED.

FOR USE IN THE EYES ONLY

See crimp tube or box for lot number and expiration date.

STORAGE: Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].

KEEP TIGHLTY CLOSED

HOW SUPPLIED:

1/8 oz (3.5g) Tube NDC 48102-017-35

Carton of Twenty (20) Unit Dose 1g Tube NDC 48102-017-20

Manufacture For: FERA
Fera Pharmaceuticals, LLC
Locust Valley, NY 11560

PF017A
Rev. 02/11

Principal Display Panel - Carton Label

Puralube

Principal Display Panel - Tube Label

Puralube

NDC 48102-017-35

FERA

Puralube® Ointment

PETROLATUM OPHTHALMIC OINTMENT

STERILE OCULAR LUBRICANT

NET WT 3.5 g (1/8 Oz)

Puralube

Mineral oil and white petrolatum OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:48102-017
Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Mineral Oil 150 mg
petrolatum 850 mg

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 3.5 in 1 TUBE
2 NDC:48102-017-11 1 in 1 TUBE
3 NDC:48102-017-20 20 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part349 2011-02-02


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Be sure to consult your doctor before taking any medication!
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