Your browser does not support JavaScript! PURALUBE (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [FERA PHARMACEUTICALS]
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PURALUBE (mineral oil and white petrolatum) ointment
[Fera Pharmaceuticals]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active ingredients

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

3.5 gram carton label

Principal Display Panel - Tube Label

3.5 gram tube label

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:48102-017
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MINERAL OIL (MINERAL OIL) MINERAL OIL150 mg  in 1 g
PETROLATUM (PETROLATUM) PETROLATUM850 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:48102-017-351 in 1 CARTON
13.5 g in 1 TUBE
2NDC:48102-017-2020 in 1 CARTON
2NDC:48102-017-111 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34902/02/2011
Labeler - Fera Pharmaceuticals (831023713)

Revised: 4/2011
 
Fera Pharmaceuticals

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