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NDC 24208-0600-99 Alaway Preservative Free 0.35 mg/mL Details

Alaway Preservative Free 0.35 mg/mL

Alaway Preservative Free 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: 24208-0600-99
Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic

Product Information

NDC	24208-0600
Product ID	24208-600_b3390c57-33f9-492b-bc81-333d41736f88
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Alaway Preservative Free
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	Bausch & Lomb Incorporated
Pharmaceutical Class	Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA208158
Listing Certified Through	2024-12-31

Package

Package Images

NDC 24208-0600-99 (24208060099)

Pricing Information	N/A
NDC Package Code	24208-600-99
Billing NDC	24208060099
Package	12 POUCH in 1 CARTON (24208-600-99) / 1 VIAL in 1 POUCH / .4 mL in 1 VIAL
Marketing Start Date	2020-09-24
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 901f53e5-c88a-40e7-848b-5814fe155089 Details

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

For external use only

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
•: discard unused portion immediately after use
•: remove contact lenses before use
•: does not include a preservative.

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 of age and older:
•: twist tab completely off to open
•: 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 between 4-25 °C (39-77 °F).
•: Use only if foil pouch is sealed and single-dose vial is intact.
•: Store unused units in foil pouch.
•: Protect from light.

Inactive ingredients

glycerin, hydrochloric acid and/or sodium hydroxide to adjust pH, and water for injection

Questions or comments?

[phone icon]Call Toll Free: 1-800-553-5340

Serious side effects associated with use of this product may be reported to this number.

Distributed by:

Bausch & Lomb Americas Inc.

Bridgewater, NJ 08807 USA

Product of Italy

Alaway is a trademark of Bausch & Lomb

Incorporated or its affiliates.

9677202

622243

Package/Label Principal Display Panel

BAUSCH + LOMB

NDC 24208-600-01

Alaway®

Preservative Free

Ketotifen Fumarate Ophthalmic Solution 0.035%

ANTIHISTAMINE EYE DROPS

Eye Itch Relief

UP TO 12HOURS

Works in Minutes

Original Prescription Strength

For Ages 3 Years And Older

10 DAY SUPPLY

20 [4 pouches x five 0.4 mL] SINGLE-DOSE VIALS

Discard unused portion

STERILE

9677202

622243

INGREDIENTS AND APPEARANCE

ALAWAY PRESERVATIVE FREE

ketotifen fumarate solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:24208-600
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
GLYCERIN (UNII: PDC6A3C0OX)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:24208-600-01	4 in 1 CARTON	09/24/2020
1		5 in 1 POUCH
1		0.4 mL in 1 VIAL; Type 0: Not a Combination Product
2	NDC:24208-600-99	12 in 1 CARTON	09/24/2020
2		1 in 1 POUCH
2		0.4 mL in 1 VIAL; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA208158	09/24/2020

Labeler - Bausch & Lomb Incorporated (196603781)

Name	Address	ID/FEI	Business Operations
Establishment
Excelvision		274234566	MANUFACTURE(24208-600)

Revised: 5/2022

Document Id: b3390c57-33f9-492b-bc81-333d41736f88

Set id: 901f53e5-c88a-40e7-848b-5814fe155089

Version: 3

Effective Time: 20220504