Search by Drug Name or NDC

NDC 69618-0060-76 Lubricant Eye PM 42.5; 57.3 g/100g; g/100g Details

Lubricant Eye PM 42.5; 57.3 g/100g; g/100g

Lubricant Eye PM is a OPHTHALMIC OINTMENT in the HUMAN OTC DRUG category. It is labeled and distributed by Reliable 1 Laboratories LLC. The primary component is MINERAL OIL; WHITE PETROLATUM.

Product Information

NDC	69618-0060
Product ID	69618-060_baec8045-97ff-6f60-e053-2a95a90a050e
Associated GPIs	86209902904220
GCN Sequence Number	065933
GCN Sequence Number Description	mineral oil/petrolatum,white OINT. (G) 42.5-57.3% OPHTHALMIC
HIC3	Q6Y
HIC3 Description	EYE PREPARATIONS, MISCELLANEOUS (OTC)
GCN	28068
HICL Sequence Number	002215
HICL Sequence Number Description	MINERAL OIL/PETROLATUM,WHITE
Brand/Generic	Generic
Proprietary Name	Lubricant Eye PM
Proprietary Name Suffix	n/a
Non-Proprietary Name	Mineral Oil, White Petrolatum
Product Type	HUMAN OTC DRUG
Dosage Form	OINTMENT
Route	OPHTHALMIC
Active Ingredient Strength	42.5; 57.3
Active Ingredient Units	g/100g; g/100g
Substance Name	MINERAL OIL; WHITE PETROLATUM
Labeler Name	Reliable 1 Laboratories LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	M018
Listing Certified Through	2024-12-31

Package

Package Images

NDC 69618-0060-76 (69618006076)

Pricing Information	N/A
NDC Package Code	69618-060-76
Billing NDC	69618006076
Package	1 TUBE in 1 CARTON (69618-060-76) / 3.5 g in 1 TUBE
Marketing Start Date	2022-01-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL baec8045-97fe-6f60-e053-2a95a90a050e Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

Active ingredients

Mineral Oil 42.5%

White Petrolatum 57.3%

SPL UNCLASSIFIED SECTION

Purpose

Eye lubricant

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

Warnings

For external use 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

condition worsens or persists for more than 72 hours
you experience eye pain, changes in vision, continued redness or irritation of the eye

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

SPL UNCLASSIFIED SECTION

Directions

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

SPL UNCLASSIFIED SECTION

Other information

store at 15°-25°C (59°-77°F)
keep tightly closed
see crimp of tube or carton for Lot Number and Expiration Date

SPL UNCLASSIFIED SECTION

Inactive ingredient

Lanolin alcohols

SPL UNCLASSIFIED SECTION

Questions or comments?

call 516-341-0666, 8:30 - 4:30 pm ET, Monday - Friday

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Allergan USA, Inc., owner of the registered trademark Refresh P.M.

Distributed by:

Reliable-1 Laboratories LLC

Valley Stream, NY 11580

www.reliable1labs.com

SPL UNCLASSIFIED SECTION

DO NOT USE IF CAP AND NECKRING ARE NOT INTACT

SAVE CARTON FOR COMPLETE DRUG FACTS

Lubricant Eye Ointment P.M. provides soothing night time relief for more intense dry, irritated eyes. Ideal for use at bedtime.

Safe to use as often as needed.

PRINCIPAL DISPLAY PANEL

Compare to Active Ingredients in Refresh P.M.®*

NDC 69618-060-76

Reliable-1® LABORATORIES

LUBRICANT EYE OINTMENT P.M.

Soothes Irritated, Dry Eyes Overnight

PRESERVATIVE FREE

Sterile

Net Wt. 1/8 OZ (3.5 g)

INGREDIENTS AND APPEARANCE

LUBRICANT EYE PM

mineral oil, white petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:69618-060
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
WHITE PETROLATUM (UNII: B6E5W8RQJ4) (WHITE PETROLATUM - UNII:B6E5W8RQJ4)	WHITE PETROLATUM	57.3 g in 100 g
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	42.5 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:69618-060-76	1 in 1 CARTON	01/01/2022
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	M018	01/01/2022

Labeler - Reliable 1 Laboratories LLC (079718111)

Revised: 8/2022

Document Id: baec8045-97ff-6f60-e053-2a95a90a050e

Set id: baec8045-97fe-6f60-e053-2a95a90a050e

Version: 1

Effective Time: 20220818

Search by Drug Name or NDC

NDC 69618-0060-76 Lubricant Eye PM 42.5; 57.3 g/100g; g/100g Details

Lubricant Eye PM 42.5; 57.3 g/100g; g/100g

Product Information

Package

Package Images

NDC 69618-0060-76 (69618006076)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL baec8045-97fe-6f60-e053-2a95a90a050e Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

Questions About Combining Hydroxyzine And Buspirone

Can You Take A Z-Pak If You Have A Penicillin Allergy?