Eye itch relief solution/ drops

Spl unclassified section

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

Otc - stop use section

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

  • eye pain
  • changes in vision
  • redness of the eye
  • itching worsens or lasts for more than 72 hours

Otc - keep out of reach of children section

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 25C (68 to 77F) [see USP Controlled Room Temperature].

Inactive ingredients

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

Questions or comments?

Serious side effects associated with use of this product may be reported to this number

1-800-932-5676

Ingredients and appearance - Product information

Eye itch relief solution/ drops- Ketotifen fumarate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 11822-4202
Route of Administration Ophthalmic

Active Ingredient/Active Moiety

Ingredient Name Strength
Ketotifen fumarate ( UNII: HBD503WORO)( Ketotifen - UNII: X49220T18G ) 0.35 mgin 1 mL

Inactive Ingredients

Ingredient Name Code
Benzalkonium chloride ( UNII: F5UM2KM3W7)
Glycerin ( UNII: PDC6A3C0OX)
Water ( UNII: 059QF0KO0R)
Hydrochloric acid ( UNII: QTT17582CB)
Sodium hydroxide ( UNII: 55X04QC32I)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
ANDA ANDA077958 USA

Labeler - Rite Aid Corporation( 014578892)

Establishment

Name ID/FEI Business Operations
Rite Aid Corporation 014578892 MANUFACTURE( 11822-4202), ANALYSIS( 11822-4202), STERILIZE( 11822-4202), PACK( 11822-4202), LABEL( 11822-4202)

Package label.principal display panel

Principal Display Panel Text for Container Label:

Rite Aid Pharmacy Logo ®

ORIGINAL

PRESCRIPTION STRENGTH

eye itch relief

ketotifen fumarate

ophthalmic solution 0.035%

antihistamine eye drops

5 mL (0.17 FL OZ) Sterile

Package label.principal display panel

Principal Display Panel Text for Carton Label:

TWIN PACK

Rite Aid Pharmacy Logo ®

*Compare to the active ingredient of Zaditor ®

ORIGINAL PRESCRIPTION STRENGTH

eye itch

relief

ketotifen fumarate

ophthalmic solution 0.035%

antihistamine eye drops

UP TO 12 HOURS ITCH RELIEF

works in minutes

for ages 3 years and older

60-day supply

2
Sterile 15 mL

(0.17 FL OZ) BOTTLES