Label: COM-PARE2 NIGHTTIME EYE- mineral oil, 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 December 20, 2022

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  • Active ingredients

    Mineral oil (20%)

    White petrolatum (80%)

  • Purpose

    Mineral oil - Eye lubricant

    White petrolatum - .Eye lubricant

  • Uses

    • May be used as a protectant against further Irritation or to relieve dryness of the eye.
  • Warnings

    • For use in eyes only.
    • Retain outer carton for full product drug facts.
    • For external use only.
    • To avoid contamination, do not touch
    • tip of container to any surface.
    • Keep tube tightly closed.

    If pregnant or breast feeding

    • If pregnant or breast feeding, ask a health professional before use.

    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.

    Keep out of reach of children.

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

  • Directions

    • Wash your hands.
    • Pull down the lower lid of the affected eye and gently apply a small amount (1/4”) of ointment to the inside of the eyelid, every 3-4 hours or as directed by a doctor.
  • Other information

    • Do not use if bottom ridge of tube is exposed, or if cap or tube is damaged.

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

    • Store away from heat. • Protect from freezing.

    • Use before expirationdate on the tube.

    • Store at 59°-86° F (15°- 30°C).

  • Questions or comments?

    Questions or comments?

    1-888-969-6855

    8 am to 4 pm; Monday - Friday.

  • Package label. Principal Display Panel

    Carton

    Label

  • INGREDIENTS AND APPEARANCE
    COM-PARE2 NIGHTTIME EYE 
    mineral oil, white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17312-404
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP, MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL200 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U, PETROLATUM - UNII:4T6H12BN9U) PETROLATUM800 mg  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17312-404-325 g in 1 TUBE; Type 0: Not a Combination Product12/20/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34712/20/2022
    Labeler - TRP Company (105185719)
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