OPTASE ALLEGRO- hydroxyethyl cellulose solution/ drops

Optase Allegro by

Drug Labeling and Warnings

Optase Allegro by is a Otc medication manufactured, distributed, or labeled by Scope Health Inc, Regulatory Matters Consulting. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

0.35% Hydroxyethyl Cellulose

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.
If swallowed get medical
help or contact a poison
control center right away.

PURPOSE

Eye Lubricant

INACTIVE INGREDIENT

Inactive ingredients: Citric Acid,
Ectoin, Purified Water, Sodium
Chloride, Trisodium Citrate Dihydrate.

DOSAGE & ADMINISTRATION

Directions:
Put one or two drops in the
affected eyes as needed.

WARNINGS

Warning
For external use only.
If solution changes color or
becomes cloudy, do not use.

To avoid contamination, do

not touch tip to any surface.

After use, shake the bottle

downwards in order to remove
any residual drop that may be left.
Replace cap after using.
Stop use and ask doctor if:

Stop use and ask doctor if
You feel eye pain.
Changes in vision occur.
Redness or irritation of the eye lasts.
Condition worsens or lasts
more than 72 hours

INDICATIONS & USAGE

Uses
For use as a lubricant to prevent
further irritation.
May be used as a protectant against
further irritation.
To relieve dryness of the eye.

Patient Information Leaflet

PRINCIPAL DISPLAY PANEL

Immediate Label

INGREDIENTS AND APPEARANCE

OPTASE ALLEGRO 
hydroxyethyl cellulose solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72972-006
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) (UNII: 8136Y38GY5) (HYDROXYETHYL CELLULOSE (140 CPS AT 5%) - UNII:8136Y38GY5)	HYDROXYETHYL CELLULOSE (140 CPS AT 5%)	0.35 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ECTOINE (UNII: 7GXZ3858RY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72972-006-01	1 in 1 BOX	03/23/2023
1		10 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M018	03/23/2023

Labeler - Scope Health Inc (116778693)

Registrant - Regulatory Matters Consulting (080711165)