Search by Drug Name or NDC

NDC 24208-0601-10 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: 24208-0601-10
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 24208-0601-10 (24208060110)

Pricing Information
NDC Package Code	24208-601-10
Billing NDC	24208060110
Package	1 BOTTLE, DROPPER in 1 CARTON (24208-601-10) / 10 mL in 1 BOTTLE, DROPPER
Marketing Start Date	2006-12-01
NDC Exclude Flag	N
Price Per Unit	0.865
Pricing Unit	ML
Effective Date	2021-10-20
NDC Description	ALAWAY 0.025% EYE DROPS
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	2, 5
Classification for Rate Setting	B
As of Date	2022-05-18

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

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