PURALUBE- light mineral oil, white petrolatum ointment

Puralube by

Drug Labeling and Warnings

Puralube by is a Otc medication manufactured, distributed, or labeled by Paddock Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Light Mineral Oil 15%

White Petrolatum 85%

Purpose

Eye Lubricant

Uses

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

Warnings

For external use only

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
• 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 right away. (1-800-222-1222)

Directions

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

Other information

• store at 20°- 25°C (68°- 77°F)
• protect from freezing
• see crimp of tube or box for lot number and expiration date.
• keep tightly closed.
• Save box for complete information.

Questions or comments?

Call 1-800-719-9260

Consumer information

PURALUBE® OINTMENT

PETROLATUM OPHTHALMIC OINTMENT

STERILE

OCULAR LUBRICANT

DESCRIPTION: a sterile ocular emollient (lubricant).

Active ingredients

Light mineral oil 15%

White petrolatum 85%

Purposes

Eye lubricant

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

Warnings:

For external use only

When using this product:

• To avoid contamination of this product do not touch the tip of the container to any surface.
• For the multi-use container: Replace the cap after using.
• For the single-use container: Do not reuse. Once opened, discard.

Stop using 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.

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

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

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

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

Store at 20 to 25°C (68 to 77°F)

KEEP TIGHTLY CLOSED

HOW SUPPLIED:

1/8 OZ (3.5 g) Tube (multi-use container) NDC 0574-4025-35

Carton of Twenty (20) Unit Dose 1 g Tube (single-use container) NDC 0574-4025-20

Manufactured for Perrigo, Minneapolis, MN 55427

Questions or comments? Call 1-800-719-9260

Rev 04-14 A

6Y000 RT J1

R0414

Ini 0414

Package/Label Principal Display Panel

Nighttime Relief

Puralube® Ointment

preservative free

prevent further irritation

relieves dryness

Petrolatum Ophthalmic Ointment

Sterile Ocular Lubricant

NET WT 3.5 g (1/8 oz)

INGREDIENTS AND APPEARANCE

PURALUBE 
light mineral oil, white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0574-4025
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIGHT MINERAL OIL (UNII: N6K5787QVP) (LIGHT MINERAL OIL - UNII:N6K5787QVP)	LIGHT MINERAL OIL	150 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	850 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0574-4025-35	1 in 1 CARTON	01/05/2015	01/01/2022
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0574-4025-20	20 in 1 CARTON	07/29/2014	11/01/2020
2	NDC: 0574-4025-11	1 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	07/28/2014	01/01/2022

Labeler - Paddock Laboratories, LLC (967694121)