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Name:Alaway
Manufacturer:Bausch & Lomb Incorporated
Category:Over-the-counter (OTC) Marketed Drugs


Drug Facts

ALAWAY - ketotifen fumarate solution/ drops 
Bausch & Lomb Incorporated

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Drug Facts

Active ingredient

Ketotifen 0.025%
(equivalent to ketotifen fumerate 0.035%)

Purpose

Antihistamine

Uses

For the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Warnings

Do not use

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

When using this product

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

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

  • eye pain
  • changes in vision
  • redness of the eyes
  • itching that 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.

Directions

Adults and children 3 years and older: 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

Store at 4-25°C (39-77°F)

Inactive ingredients

benzalkonium chloride, 0.01%, glycerin, sodium hydroxide and/or hydrochloric acid and water for injection.

Questions or Comments?

Toll Free Product Information Call: 1-800-553-5340

Package/Label Principal Display Panel

Alaway, Ketotifen Fumarate Ophthalmic Solution Antihistamine Eye Drops (Carton, 10 mL - Bausch & Lomb)

NDC 24208-601-10

Bausch & Lomb

Alaway

KETOTIFEN FUMARATE OPHTHALMIC SOLUTION

ANTIHISTAMINE EYE DROPS

60 Day Supply

Up To 12 Hours

Eye Itch Relief in Minutes!

▪ Original Prescription Strength

▪ Adults and children 3 years and older

STERILE 0.34 FL OZ (10 mL)


ALAWAY 
ketotifen fumarate solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:24208-601
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOTIFEN FUMARATE (KETOTIFEN) KETOTIFEN FUMARATE 0.345 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN  
SODIUM HYDROXIDE  
HYDROCHLORIC ACID  
WATER  
BENZALKONIUM CHLORIDE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24208-601-10 1 BOTTLE, DROPPER ( BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
1 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (24208-601-10)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021996 12/01/2006

Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
Name Address ID/FEI Operations
Bausch & Lomb Incorporated 807927397 MANUFACTURE
Establishment
Name Address ID/FEI Operations
SIFAVITOR SRL 438904398 API MANUFACTURE

Revised: 12/2010 Bausch & Lomb Incorporated



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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