RETAINE PM- mineral oil, white petrolatum ointment

retaine PM by

Drug Labeling and Warnings

retaine PM by is a Otc medication manufactured, distributed, or labeled by OCuSOFT, Inc., Galentic Pharma (India) Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Mineral oil (20%)
White petrolatum (80%)

Purpose

Eye lubricant

Uses

As a lubricant to prevent further irritaion or to relieve dryness of the eye(s).

Warnings

For use in the eyes only.

When using this product

● do not touch tip of container to any surface to avoid contamination.
● replace cap after 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.

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

Directions

● Pull down the lower lid of the affected eye(s).
● Apply a small amount (1/4 inch) of ointment to the inside of the eyelid.

Other information

● Do not use if cap breakaway seal is broken or missing.
● Store between 15°-30°C (59°-86°F).
● Keep this carton for full product information.

Questions?

☎ Call
(800) 233-5469 M-F
8:30AM-5:00PM CST
or visit retainebrand.com

Package label. Principal Display Panel

INGREDIENTS AND APPEARANCE

RETAINE PM  
mineral oil, white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54799-893
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Mineral Oil (UNII: T5L8T28FGP) (Mineral Oil - UNII:T5L8T28FGP, Mineral Oil - UNII:T5L8T28FGP)	Mineral Oil	200 mg  in 1 g
Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U, Petrolatum - UNII:4T6H12BN9U)	Petrolatum	800 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54799-893-05	5 g in 1 TUBE; Type 0: Not a Combination Product	09/02/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	09/02/2013

Labeler - OCuSOFT, Inc. (174939207)

Registrant - OCuSOFT, Inc. (174939207)

Establishment
Name	Address	ID/FEI	Business Operations
Galentic Pharma (India) Private Limited		650970176	manufacture(54799-893)