Label: COM-PARE2 NIGHTTIME 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 December 20, 2022

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  • Active Ingredients

    Mineral oil 3%

    White petrolatum 94%

  • PURPOSE

    Mineral oil .....Eye lubricant

    White petrolatum.....Eye lubricant

  • Uses

    • For temporary relief of irritation or dryness in the eye.

    • May be used as a protectant against further irritation.

  • 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.

    Stop use and ask a doctor

    Stop use and ask a doctor if:

    • You experience eye pain, changes invision, 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 (1-800-222-1222) right away.

    If pregnant or breast feeding

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

  • 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 expiration date on the tube.
    • Store at 59°-86° F (15°- 30°C).
  • Inactive ingredient

    Lanolin alcohol.

  • QUESTIONS

    Questions? In the U.S. call 1-800-757-9195 alcon.medinfo@alcon.com www.systane.com

  • PRINCIPAL DISPLAY PANEL

    Carton

    Label

  • INGREDIENTS AND APPEARANCE
    COM-PARE2 NIGHTTIME EYE 
    mineral oil and white petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17312-403
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) MINERAL OIL30 mg  in 1 g
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM940 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17312-403-321 in 1 CARTON12/19/2022
    13.5 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34912/19/2022
    Labeler - TRP Company (105185719)
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