Label: GOOD NEIGHBOR PHARMACY EYE ITCH RELIEF- ketotifen fumarate solution
- NDC Code(s): 68258-8900-5
- Packager: Dispensing Solutions, Inc.
- This is a repackaged label.
- Source NDC Code(s): 24385-494
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- Active ingredient
(equivalent to ketotifen fumarate 0.035%)Close
Temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander.Close
Do not use
. If solution changes color or becomes cloudyi
. 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 useClose
- 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 hoursClose
- Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)Close
. Adults and children 3 years of age 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.Close
- Other information
. Only for use in the eye
. Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]Close
- Inactive ingredients
benzalkonium chloride 0.01%, glycerin, purified water. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).Close
- Questions or comments?
- PACKAGE LABEL PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
GOOD NEIGHBOR PHARMACY EYE ITCH RELIEF
ketotifen fumarate solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68258-8900(NDC:24385-494) Route of Administration OPHTHALMIC DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G) KETOTIFEN 0.25 mg in 1 mL Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) HYDROCHLORIC ACID (UNII: QTT17582CB) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68258-8900-5 5 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077958 11/13/2010 Labeler - Dispensing Solutions, Inc. (066070785) Registrant - PSS World Medical, Inc. (101822682) Establishment Name Address ID/FEI Business Operations Dispensing Solutions, Inc. 066070785 relabel(68258-8900) , repack(68258-8900)