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NDC 00536-1325-94 Rugby Lubricating Drops 14 mg/mL Details

Rugby Lubricating Drops 14 mg/mL

Rugby Lubricating Drops is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby. The primary component is POLYVINYL ALCOHOL.

Product Information

NDC	00536-1325
Product ID	0536-1325_c0549236-9a47-3306-e053-2995a90a2011
Associated GPIs	86200050002030
GCN Sequence Number	007936
GCN Sequence Number Description	polyvinyl alcohol DROPS 1.4 % OPHTHALMIC
HIC3	Q6T
HIC3 Description	ARTIFICIAL TEARS
GCN	33422
HICL Sequence Number	005225
HICL Sequence Number Description	POLYVINYL ALCOHOL
Brand/Generic	Generic
Proprietary Name	Rugby Lubricating Drops
Proprietary Name Suffix	n/a
Non-Proprietary Name	Polyvinyl Alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	14
Active Ingredient Units	mg/mL
Substance Name	POLYVINYL ALCOHOL
Labeler Name	Rugby
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2022-12-31

Package

Package Images

NDC 00536-1325-94 (00536132594)

Pricing Information
NDC Package Code	0536-1325-94
Billing NDC	00536132594
Package	15 mL in 1 BOTTLE (0536-1325-94)
Marketing Start Date	2021-04-19
NDC Exclude Flag	N
Price Per Unit	0.30523
Pricing Unit	ML
Effective Date	2023-11-22
NDC Description	POLYVINYL ALCOHOL 1.4% EYEDROP
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	4, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL c0549236-9a46-3306-e053-2995a90a2011 Details

Active ingredient

Polyvinyl Alcohol 1.4%

Purpose

Lubricant

Uses

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

Warnings

Do not use if solution changes color or becomes cloudy

When using this product

do not touch tip of container to any surface to avoid contamination
remove contact lens before using.
replace cap after using.
keep container tightly closed

Stop use and ask a doctor if

you experience 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

instill 1 to 2 drops in the affected eye(s) as needed

Other information

store at room temperature
keep tightly closed
replace cap after use
retain carton for full drug facts

Inactive ingredients

dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate,

purified water, sodium chloride. Phosphoric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVE ADDED: benzalkonium chloride 0.01%

Questions ?

Call 1-800-645-2158

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

RUGBY LUBRICATING DROPS

polyvinyl alcohol solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1325
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYVINYL ALCOHOL (UNII: 532B59J990) (POLYVINYL ALCOHOL - UNII:532B59J990)	POLYVINYL ALCOHOL	14 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
WATER (UNII: 059QF0KO0R)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0536-1325-94	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/19/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	04/19/2021

Labeler - Rugby (079246066)

Revised: 4/2021

Document Id: c0549236-9a47-3306-e053-2995a90a2011

Set id: c0549236-9a46-3306-e053-2995a90a2011

Version: 1

Effective Time: 20210419