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NDC 00536-1282-94 Lubricating Eye Drops 1; 3 mg/mL; mg/mL Details

Lubricating Eye Drops 1; 3 mg/mL; mg/mL

Lubricating Eye Drops is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. The primary component is DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S).

Product Information

NDC	00536-1282
Product ID	0536-1282_edf2e6c4-5458-b813-e053-2a95a90a864d
Associated GPIs	86209902242020
GCN Sequence Number	063561
GCN Sequence Number Description	dextran 70/hypromellose DROPS 0.1%-0.3% OPHTHALMIC
HIC3	Q6T
HIC3 Description	ARTIFICIAL TEARS
GCN	99283
HICL Sequence Number	003495
HICL Sequence Number Description	DEXTRAN 70/HYPROMELLOSE
Brand/Generic	Generic
Proprietary Name	Lubricating Eye Drops
Proprietary Name Suffix	n/a
Non-Proprietary Name	dextran 70 and hypromellose 2910
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	1; 3
Active Ingredient Units	mg/mL; mg/mL
Substance Name	DEXTRAN 70; HYPROMELLOSE 2910 (4000 MPA.S)
Labeler Name	Rugby Laboratories
Pharmaceutical Class	Increased Intravascular Volume [PE], Osmotic Activity [MoA], Plasma Volume Expander [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2023-12-31

Package

Package Images

NDC 00536-1282-94 (00536128294)

Pricing Information	N/A
NDC Package Code	0536-1282-94
Billing NDC	00536128294
Package	1 BOTTLE, DROPPER in 1 CARTON (0536-1282-94) / 15 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2020-01-22
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL f5712fe5-fb2b-4c7d-865e-d3984bb5c4e4 Details

SPL UNCLASSIFIED SECTION

Active Ingredients	Purpose
Dextran 70 0.1%	Lubricant
Hypromellose 2910 0.3%	Lubricant

Uses

temporary relief of burning and irritation due to dryness of the eye
temporary relief of discomfort due to minor irritations of the eye or to exposure to wind or sun
as a protectant against further irritation

Warnings

For external use only

Do not use

if solution changes color or becomes cloudy
if you are sensitive to any ingredient in this product

When using this product

to avoid contamination, do not touch tip of container to any surface
replace cap after using

SPL UNCLASSIFIED SECTION

Stop use and ask a doctor if you experience any of the following:

eye pain
changes in vision
continued redness or irritation of the eye
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

put 1 or 2 drops in the affected eye(s) as needed

Other information

store at room temperature

Inactive ingredients:

boric acid, calcium chloride, glycerin, glycine, magnesium chloride, polysorbate 80, potassium chloride, purified water, sodium borate, sodium chloride, stabilized oxychoro complex, zinc chloride. May contain hydrocholric acid and/or sodium hydroxide to adjust pH.

Questions?

Call 1-800-645-2158

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

LUBRICATING EYE DROPS

dextran 70 and hypromellose 2910 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1282
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68)	DEXTRAN 70	1 mg in 1 mL
HYPROMELLOSE 2910 (4000 MPA.S) (UNII: RN3152OP35) (HYPROMELLOSE 2910 (4000 MPA.S) - UNII:RN3152OP35)	HYPROMELLOSE 2910 (4000 MPA.S)	3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BORIC ACID (UNII: R57ZHV85D4)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCINE (UNII: TE7660XO1C)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CHLORITE (UNII: G538EBV4VF)
ZINC CHLORIDE (UNII: 86Q357L16B)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0536-1282-94	1 in 1 CARTON	01/22/2020
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	01/22/2020

Labeler - Rugby Laboratories (079246066)

Registrant - Velocity Pharma LLC (962198409)

Revised: 11/2022

Document Id: edf2e6c4-5458-b813-e053-2a95a90a864d

Set id: f5712fe5-fb2b-4c7d-865e-d3984bb5c4e4

Version: 5

Effective Time: 20221120

Search by Drug Name or NDC

NDC 00536-1282-94 Lubricating Eye Drops 1; 3 mg/mL; mg/mL Details

Lubricating Eye Drops 1; 3 mg/mL; mg/mL

Product Information

Package

Package Images

NDC 00536-1282-94 (00536128294)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL f5712fe5-fb2b-4c7d-865e-d3984bb5c4e4 Details

SPL UNCLASSIFIED SECTION

Uses

Warnings

Do not use

When using this product

SPL UNCLASSIFIED SECTION

Keep out of reach of children.

Directions

Other information

Inactive ingredients:

Questions?

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