PURALUBE- light mineral oil, white petrolatum ointment 
Paddock Laboratories, LLC

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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Puralube® Ointment Drug Facts

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)

puralube-image
PURALUBE 
light mineral oil, white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0574-4025
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP) (LIGHT MINERAL OIL - UNII:N6K5787QVP) LIGHT MINERAL OIL150 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM850 mg  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0574-4025-351 in 1 CARTON01/05/201501/01/2022
13.5 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0574-4025-2020 in 1 CARTON07/29/201411/01/2020
2NDC:0574-4025-111 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34907/28/201401/01/2022
Labeler - Paddock Laboratories, LLC (967694121)

Revised: 4/2019
 
Paddock Laboratories, LLC