KETOTIFEN FUMARATE- ketotifen fumarate solution 
Bayshore Pharmaceuticals, LLC

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Drug Facts

Active ingredient

Ketotifen (0.025%)

(equivalent to ketotifen fumarate 0.035%)

Purpose

Antihistamine

Use

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

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

Stop use and ask a doctor if

you experience any of the following:

  • eye pain
  • changes in vision
  • redness of the eye
  • itching 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

Other information

Inactive ingredients

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

Questions?

Call Product Information at 973-315-1818. Serious side effects associated with use of this product may be reported to this number.

Code No.: GO/DRUGS/557

Manufactured For:
Bayshore Pharmaceuticals
LLC., Short Hills, NJ 07078
Made in India.

Principal Display Panel - Bottle Label

NDC 76385-106-17

Ketotifen Fumarate Opthalmic Solution 0.035%

ANTIHISTAMINE EYE DROPS

5 mL (0.17 FL OZ)

Sterile

ketotifenfumaratelabel

Principal Display Panel - Bottle Carton

NDC 76385-106-17

Now OTC

Ketotifen Fumarate Opthalmic Solution 0.035%

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS

Eye Itch Relief

Works in Minutes

Original Prescription Strength

for ages 3 years and older

20 day supply

5 mL (0.17 FL OZ)

Sterile

ketotifenfumaratecarton

KETOTIFEN FUMARATE 
ketotifen fumarate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76385-106
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOTIFEN FUMARATE (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G) Ketotifen 0.25 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76385-106-171 in 1 CARTON10/15/2021
15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20405910/15/2021
Labeler - Bayshore Pharmaceuticals, LLC (968737416)

Revised: 10/2021
Document Id: ca50459a-8472-4a04-bae3-51f27113c37d
Set id: 0fe119ad-cb44-4e90-a096-0ed0ba63dc31
Version: 1
Effective Time: 20211015
 
Bayshore Pharmaceuticals, LLC