FDA Label for Eye Itch

View Indications, Usage & Precautions

OTHER
ACTIVE INGREDIENT
PURPOSE
USES
DO NOT USE
WHEN USING THIS PRODUCT
OTC - STOP USE
KEEP OUT OF REACH OF CHILDREN.
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Eye Itch Product Label

The following document was submitted to the FDA by the labeler of this product Kroger Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Other

Drug Facts

Active Ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Uses

Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.

Do Not Use

if solution changes color or becomes cloudy
if you are sensitive to any ingredient in this product
to treat contact lens related irritation

When Using This Product

do not touch tip of container to any surface to avoid contamination
remove contact lenses before use
wait at least 10 minutes before reinserting contact lenses after use
replace cap after each use

Otc - Stop Use

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

eye pain
charges in vision
redness of the eye
itching worsens or lasts more than 72 hours

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222)

Directions

Adults and children 3 years of age and older:
Put 1 drop in the affected eye(s) twice daily, every 8 to 12 hours no more than twice per day.
Children under 3 years of age: Consult a doctor.

Other Information

only for use in the eye
store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Inactive Ingredients

Benzalkonium Chloride 0.01% Glycerin, Purified Water. May contain Hydrochloric Acid and/or Sodium Hydroxide to adjust pH.

Questions Or Comments?

1-800-632-6900

Package Label.Principal Display Panel

Principal Display Panel Text for Container Label:

NDC 30142-702-01

Kroger Logo^®

STERILE

Eye Itch

Relief Drops

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine

Eye Drops 5 mL

(0.17 FL OZ)

Principal Display Panel Text for Carton Label:

COMPARE TO the active ingredient of

Zaditor^® *See side panel