PURALUBE (LIGHT MINERAL OIL, WHITE PETROLATUM) OINTMENT [PADDOCK LABORATORIES, LLC]

PURALUBE (LIGHT MINERAL OIL, WHITE PETROLATUM) OINTMENT [PADDOCK LABORATORIES, LLC]
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NDC 0574-4025-11, 0574-4025-20, 0574-4025-35
Set ID 4b8ca103-c863-492b-adc5-9691f01e795b
Category HUMAN OTC DRUG LABEL
Packager Paddock Laboratories, LLC
Generic Name
Product Class
Product Number
Application Number PART349
  • 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
  • INGREDIENTS AND APPEARANCE
    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)