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NDC 00363-0038-10 Eye Itch Relief 0.35 mg/mL Details
Eye Itch Relief 0.35 mg/mL
Eye Itch Relief is a OPHTHALMIC SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Walgreen Company. 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: 00363-0038-10Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic
Product Information
| NDC | 00363-0038 |
|---|---|
| Product ID | 0363-0038_bf649c66-1a18-4c11-98dc-922701ae4b17 |
| Associated GPIs | 66100020000105 |
| 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 | Eye Itch Relief |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ketotifen fumarate |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 0.35 |
| Active Ingredient Units | mg/mL |
| Substance Name | KETOTIFEN FUMARATE |
| Labeler Name | Walgreen Company |
| 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 00363-0038-10 (00363003810)
| NDC Package Code | 0363-0038-10 |
|---|---|
| Billing NDC | 00363003810 |
| Package | 1 BOTTLE in 1 CARTON (0363-0038-10) / 10 mL in 1 BOTTLE |
| Marketing Start Date | 2013-09-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9ce8f926-c202-40d1-9dba-0477f1f49e14 Details
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 content 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.
Directions
Inactive ingredients
Package/Label Principal Display Panel
VALUE SIZE
NDC 0363-0038-10
Walgreens
Compare to the active ingredient in
Zaditor®††
Eye Itch
Relief
ketotifen fumarate
ophthalmic solution 0.035%
ANTIHISTAMINE EYE DROPS
Up to 12 Hours
- •
- Original prescription strength
- •
- Works in minutes
- •
- 60 day supply
- •
- For ages 3
years and older - •
- STERILE
0.34 FL OZ (10 mL)
Package/Label Principal Display Panel
VALUE SIZE
NDC 0363-0038-10
Walgreens
Compare to the active
ingredient in Alaway®††
Eye Itch
Relief
ketotifen fumarate
ophthalmic solution 0.035%
ANTIHISTAMINE EYE DROPS
Up to 12 Hours
- •
- Original prescription strength
- •
- Works in minutes
- •
- 60 day supply
- •
- For ages 3 years
and older - •
- STERILE
0.34 FL OZ (10 mL)
INGREDIENTS AND APPEARANCE
| EYE ITCH RELIEF
ketotifen fumarate solution |
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| Labeler - Walgreen Company (008965063) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Bausch & Lomb Incorporated | 079587625 | MANUFACTURE(0363-0038) | |