Label: NIGHTIME RELIEF LUBRICANT EYE- mineral oil, and white petrolatum ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated March 5, 2015

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  • ACTIVE INGREDIENT

    Active ingredients                                                          Purpose

    Mineral oil 42.5%........................................................ Eye Lubricant

    White petrolatum 57.3%.............................................. Eye Lubricant

  • PURPOSE

    Uses

    • For the temporary relief of burning, irritation, and discomfort due to dryness or the eye or exposure to wind or sun.
    • May be used as a protectant against further irritation
  • WARNINGS

    Warnings

    • For external use only.
    • To avoid contamination, do not touch tip of contaainer to any surface. Replace cap after using.
  • STOP USE

    Stop use and ask a doctor if you experience eye pain, changes in vision, continued reness or irritation of the eye, or if the condition worsens or persists more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

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

  • INDICATIONS & USAGE

    Directions

    Pull down the lower lid of the affected eye and apply a small amount (1/4") of ointment to the inside of the eyelid

  • STORAGE AND HANDLING

    Other information

    • store away from heat
    • protect from freezing
    • use before expiration date marked on container
    • store at 59°-86° (15°-30°)
  • INACTIVE INGREDIENT

    Inactive ingredient

    lanolin alcohol

  • DOSAGE & ADMINISTRATION

    DISTRIBUTED BY:

    TARGET CORP.

    MINNEAPOLIS, MN 55403

    MADE IN KOREA

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    NIGHTIME RELIEF LUBRICANT EYE 
    mineral oil, and white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11673-575
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL425 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM533 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN ALCOHOLS (UNII: 884C3FA9HE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11673-575-121 in 1 BOX
    13.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34903/05/2015
    Labeler - Target Corporation (006961700)
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