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NDC 71205-0115-05 Ketotifen Fumarate 0.35 mg/mL Details

Ketotifen Fumarate 0.35 mg/mL

Ketotifen Fumarate is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Proficient Rx LP. The primary component is KETOTIFEN FUMARATE.

MedlinePlus Drug Summary

Ophthalmic ketotifen is used to relieve the itching of allergic pinkeye. Ketotifen is in a class of medications called antihistamines. It works by blocking histamine, a substance in the body that causes allergic symptoms.

Related Packages: 71205-0115-05
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic

Product Information

NDC	71205-0115
Product ID	71205-115_78139082-90f2-4200-bf95-8a46315597ed
Associated GPIs	86802040102010
GCN Sequence Number	043118
GCN Sequence Number Description	ketotifen fumarate DROPS 0.025 % OPHTHALMIC
HIC3	Q6R
HIC3 Description	EYE ANTIHISTAMINES
GCN	92451
HICL Sequence Number	006554
HICL Sequence Number Description	KETOTIFEN FUMARATE
Brand/Generic	Generic
Proprietary Name	Ketotifen Fumarate
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ketotifen Fumarate
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	0.35
Active Ingredient Units	mg/mL
Substance Name	KETOTIFEN FUMARATE
Labeler Name	Proficient Rx LP
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA077958
Listing Certified Through	2024-12-31

Package

Package Images

NDC 71205-0115-05 (71205011505)

Pricing Information	N/A
NDC Package Code	71205-115-05
Billing NDC	71205011505
Package	1 BOTTLE, DROPPER in 1 CARTON (71205-115-05) / 5 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2018-09-04
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 3a9e70ab-d188-488c-8c47-a2184eb4ef2c Details

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

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

•: 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.

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 and Purified Water. May contain Hydrochloric Add and/or Sodium Hydroxide (to adjust pH).

Questions?

call toll-free 1-800-932-5676, weekdays, 7:00 AM - 5:30 PM CST

PRINCIPAL DISPLAY PANEL

Principal Display Panel Text for Carton Label:

Now OTC! NDC 71205-115-05

Ketotifen

Fumarate

Ophthalmic

Solution

ANTIHISTAMINE EYE DROPS

UP TO 12 HOURS EYE ITCH RELIEF

Works in Minutes

Original Prescription Strength

FOR AGES 3 YEARS AND OLDER

30 DAY SUPPLY

5 mL (0.17 FL OZ) Sterile

INGREDIENTS AND APPEARANCE

KETOTIFEN FUMARATE

ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71205-115(NDC:17478-717)
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ketotifen fumarate (UNII: HBD503WORO) (Ketotifen - UNII:X49220T18G)	Ketotifen	0.35 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
benzalkonium chloride (UNII: F5UM2KM3W7)
glycerin (UNII: PDC6A3C0OX)
water (UNII: 059QF0KO0R)
hydrochloric acid (UNII: QTT17582CB)
sodium hydroxide (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:71205-115-05	1 in 1 CARTON	09/04/2018
1		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077958	10/01/2007

Labeler - Proficient Rx LP (079196022)

Name	Address	ID/FEI	Business Operations
Establishment
Proficient Rx LP		079196022	RELABEL(71205-115)

Revised: 10/2019

Document Id: 78139082-90f2-4200-bf95-8a46315597ed

Set id: 3a9e70ab-d188-488c-8c47-a2184eb4ef2c

Version: 3

Effective Time: 20191001