FDA Label for Alaway Preservative Free
View Indications, Usage & Precautions
Alaway Preservative Free Product Label
The following document was submitted to the FDA by the labeler of this product Bausch & Lomb Incorporated. 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.
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.
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• to treat contact lens related irritation• do not touch tip of container to any surface to avoid contamination• discard unused portion immediately after use• remove contact lenses before use• does not include a preservative.• eye pain• changes in vision• redness of the eyes• itching that worsens or lasts for more than 72 hours
When using this product
Stop use and ask a doctor if you experience any of the following:
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Adults and children 3 years of age and older:
• twist tab completely off to open• put 1 drop in the affected eye(s) twice daily, every 8-12 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 between 4°-25° C (39°-77° F).• Use only if foil pouch is sealed and single-dose vial is intact.• Store unused units in foil pouch.• Protect from light.
Inactive Ingredients
glycerin, hydrochloric acid and/or sodium hydroxide to adjust pH, and water for injection
Questions Or Comments?
[phone icon] Call Toll Free: 1-800-553-5340
Serious side effects associated with use of this product may be reported to this number
9677200
622243
Package/Label Principal Display Panel
NEW
PRODUCT
BAUSCH + LOMB
NDC 24208-600-01
Alaway®
Preservative Free
Ketotifen Fumarate Ophthalmic Solution 0.035%
ANTIHISTAMINE EYE DROPS
Eye Itch Relief
UP TO
12
HOURS
Works in Minutes
Original Prescription Strength
For Ages 3 Years And Older
10 DAY SUPPLY
20 (4 pouches x five 0.4 mL) SINGLE-DOSE VIALS
Discard unused portion
STERILE
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