Search by Drug Name or NDC

NDC 24208-0601-90 Alaway 0.25 mg/mL Details

Alaway 0.25 mg/mL

Alaway is a OPHTHALMIC SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Bausch & Lomb Incorporated. 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: 24208-0601-90
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic

Product Information

NDC	24208-0601
Product ID	24208-601_4f27a942-b5f3-4a01-8022-49deced585f8
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	Brand
Proprietary Name	Alaway
Proprietary Name Suffix	n/a
Non-Proprietary Name	Ketotifen Fumarate
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	OPHTHALMIC
Active Ingredient Strength	0.25
Active Ingredient Units	mg/mL
Substance Name	KETOTIFEN FUMARATE
Labeler Name	Bausch & Lomb Incorporated
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
DEA Schedule	n/a
Marketing Category	NDA
Application Number	NDA021996
Listing Certified Through	2024-12-31

Package

Package Images

NDC 24208-0601-90 (24208060190)

Pricing Information	N/A
NDC Package Code	24208-601-90
Billing NDC	24208060190
Package	2 BOTTLE, DROPPER in 1 CARTON (24208-601-90) / 10 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2006-12-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL e4c310b5-1dba-4ddc-bc90-b27ebc765871 Details

Active ingredient

Ketotifen 0.025%

(equivalent to ketotifen fumerate 0.035%)

Purpose

Antihistamine

Uses

for the temporary relief of itchy eyes due to ragweed, pollen, grass, animal hair and dander.

Warnings

For external use only

Do not use

•: if you are sensitive to any ingredient in this product
•: if solution changes color or becomes cloudy
•: to treat contact lens related irritation

When using this product

•: remove contact lenses before use
•: wait at least 10 minutes before re-inserting contact lenses after use
•: do not touch tip of container to any surface to avoid contamination
•: 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 eyes
•: itching that 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 and older:

•: put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day
•: if using other ophthalmic products while using this product, wait at least 5 minutes between each product

•

children under 3 years of age: consult a doctor

Other information

store at 4-25 °C (39-77 °F)

Inactive ingredients

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

Questions or comments?

[Phone icon] Call: 1-800-553-5340

Package/Label Principal Display Panel

TWIN PACK

NDC 24208-601-90

BAUSCH + LOMB

Alaway®

ketotifen fumarate

ophthalmic solution 0.035%

ANTIHISTAMINE EYE DROPS

Eye Itch

Relief

UP TO

12

HOURS

Works in Minutes

Original Prescription Strength

For Ages 3 Years And Older

2x 10 mL BOTTLES

STERILE 0.34 FL OZ EACH

3842002

AB60192A

INGREDIENTS AND APPEARANCE

ALAWAY

ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24208-601
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
KETOTIFEN FUMARATE (UNII: HBD503WORO) (KETOTIFEN - UNII:X49220T18G)	KETOTIFEN	0.25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:24208-601-10	1 in 1 CARTON	12/01/2006
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
2	NDC:24208-601-95	1 in 1 CARTON	12/01/2006	09/30/2015
2		1 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
3	NDC:24208-601-05	1 in 1 CARTON	12/01/2006
3		5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
4	NDC:24208-601-90	2 in 1 CARTON	12/01/2006
4		10 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
NDA	NDA021996	12/01/2006

Labeler - Bausch & Lomb Incorporated (196603781)

Name	Address	ID/FEI	Business Operations
Establishment
Bausch & Lomb Incorporated		079587625	MANUFACTURE(24208-601)

Revised: 5/2022

Document Id: 4f27a942-b5f3-4a01-8022-49deced585f8

Set id: e4c310b5-1dba-4ddc-bc90-b27ebc765871

Version: 15

Effective Time: 20220501