OTC Medication Information: Artificial Tears

ARTIFICIAL TEARS- polyvinyl alcohol, unspecified solution/ drops
Preferred Pharmaceuticals, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active ingredient

Polyvinyl Alcohol 1.4%

Purpose

Lubricant

Uses

relieves dryness of the eye
prevents further irritation

Warnings

Do not use if solution changes color or becomes cloudy
with contact lenses

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
condition worsens or lasts 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 15° — 30°C (59° — 86°F)
keep tightly closed

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 or comments?

Call 1-800-645-2158

9 am — 5 pm ET, Monday-Friday.

Serious side effects associated with use of this product may be reported to this number

How Supplied

15 mL – 68788-9858-1

Rugby ®

Duluth, GA 30097

Relabeled By Preferred Pharmaceuticals, Inc.

Package/Label Principal Display Panel

Artificial Tears Lubricant Eye Drops
(click image for full-size original)
ARTIFICIAL TEARS
polyvinyl alcohol solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-9858(NDC:0536-1970)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYVINYL ALCOHOL, UNSPECIFIED (POLYVINYL ALCOHOL) POLYVINYL ALCOHOL, UNSPECIFIED 14 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
EDETATE DISODIUM
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM
SODIUM CHLORIDE
WATER
BENZALKONIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-9858-1 15 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part349 03/13/2012
Labeler — Preferred Pharmaceuticals, Inc (791119022)
Registrant — Preferred Pharmaceuticals, Inc (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc 791119022 RELABEL (68788-9858)

Revised: 03/2018 Preferred Pharmaceuticals, 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.

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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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