OTC Medication Information: REFRESH P.M.

REFRESH P.M.- mineral oil and petrolatum ointment
Allergan, Inc.

Active ingredients

Mineral Oil 42.5%

White Petrolatum 57.3%

Purpose

Eye lubricant

Eye lubricant

Uses

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

Warnings

  • For external use only.

  • To 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, or if 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.

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.

Other information

  • Store away from heat.

  • Protect from freezing.

  • Use only if tape seals on top and bottom flaps are intact.

  • Use before expiration date marked on container.

  • Store at 59°-77°F (15°-25°C).

  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

Inactive ingredients

Lanolin alcohols.

Questions or comments?

1.800.678.1605

refreshbrand.com

v1.0DFL0667

PRINCIPAL DISPLAY PANEL

NDC 0023-0667-04
PRESERVE-FREE
Lubricant Eye Ointment
For Eye Dryness
Refresh
P.M.®
Nighttime Relief for
Intense Eye DrynessNet wt. 0.12 oz (3.5 g) Sterile

NDC 0023-0667-04
PRESERVE-FREE
Lubricant Eye Ointment
For Eye Dryness
Refresh
P.M. ®
Nighttime Relief for
Intense Eye Dryness
Net wt. 0.12 oz (3.5 g) Sterile
(click image for full-size original)

PRINCIPAL DISPLAY PANEL

NDC 0023-0240-04
Refresh
P.M.
Lubricant Eye Ointment
NIGHTTIME OINTMENTNet wt. 0.12 oz (3.5 g) Sterile

NDC 0023-0240-04
Refresh
P.M.
Lubricant Eye Ointment
 NIGHTTIME OINTMENT
Net wt. 0.12 oz (3.5 g) Sterile
(click image for full-size original)
REFRESH P.M. mineral oil, petrolatum ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0023-0240
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
mineral oil (mineral oil) mineral oil 425 mg in 1 g
petrolatum (petrolatum) petrolatum 573 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
lanolin alcohols
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-0240-21 1 TUBE in 1 CARTON contains a TUBE
1 3.5 g in 1 TUBE This package is contained within the CARTON (0023-0240-21)
2 NDC:0023-0240-04 1 TUBE in 1 CARTON contains a TUBE
2 3.5 g in 1 TUBE This package is contained within the CARTON (0023-0240-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M018 04/23/1990
REFRESH P.M. mineral oil, petrolatum ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0023-0667
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
mineral oil (mineral oil) mineral oil 425 mg in 1 g
petrolatum (petrolatum) petrolatum 573 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
lanolin alcohols
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0023-0667-04 1 TUBE in 1 CARTON contains a TUBE
1 3.5 g in 1 TUBE This package is contained within the CARTON (0023-0667-04)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M018 08/26/2016
Labeler — Allergan, Inc. (144796497)

Revised: 06/2022 Allergan, Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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