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Eye Itch Relief by H E B

Medically reviewed on Feb 26, 2018

Dosage form: solution/ drops
Ingredients: Ketotifen Fumarate 0.35mg in 1mL
Labeler: H E B
NDC Code: 37808-802

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.

Warnings

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 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 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?

1-800-932-5676

Principal Display Panel Text for Container Label:

H ■ E ■ B Logo®

NDC 37808-802-01

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

STERILE 5 mL (0.17 FL OZ)

Principal Display Panel Text for Carton Label:

NDC 37808-802-01 Compare to

the active

ingredients

in Zaditor®*

H ■ E ■ B Logo®

Eye Itch

Relief

Ketotifen Fumarate

Ophthalmic Solution

Antihistamine Eye Drops

Eye Drops

• Works in

Minutes

• Original

Prescription

Strength

• For ages

3 years

& Older

UP TO

12

HOURS

ITCH RELIEF

STERILE 5 mL (0.17 FL OZ)

EYE ITCH RELIEF 
ketotifen fumarate solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37808-802
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ketotifen Fumarate (Ketotifen) Ketotifen0.35 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Benzalkonium Chloride 
Glycerin 
Water 
Hydrochloric Acid 
Sodium Hydroxide 
Packaging
#Item CodePackage Description
1NDC:37808-802-011 BOTTLE, DROPPER in 1 CARTON
15 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07795802/25/2014
Labeler - H E B (007924756)
Registrant - Akorn, Inc. (062649876)
Establishment
NameAddressID/FEIOperations
Akorn, Inc603980319MANUFACTURE(37808-802), ANALYSIS(37808-802), STERILIZE(37808-802), PACK(37808-802), LABEL(37808-802)

 
H E B

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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