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NDC 72189-0114-05 KETOTIFEN FUMARATE 0.25 mg/mL Details
KETOTIFEN FUMARATE 0.25 mg/mL
KETOTIFEN FUMARATE is a OPHTHALMIC SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by DIRECT RX. 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: 72189-0114-05Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Ketotifen Ophthalmic
Product Information
| NDC | 72189-0114 |
|---|---|
| Product ID | 72189-114_c2d7d12d-4186-6bde-e053-2995a90a538e |
| Associated GPIs | 86802040102010 |
| 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 | KETOTIFEN FUMARATE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | KETOTIFEN FUMARATE |
| Product Type | HUMAN OTC DRUG |
| Dosage Form | SOLUTION |
| Route | OPHTHALMIC |
| Active Ingredient Strength | 0.25 |
| Active Ingredient Units | mg/mL |
| Substance Name | KETOTIFEN FUMARATE |
| Labeler Name | DIRECT RX |
| Pharmaceutical Class | Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077354 |
| Listing Certified Through | 2023-12-31 |
Package
Package Images
NDC 72189-0114-05 (72189011405)
| NDC Package Code | 72189-114-05 |
|---|---|
| Billing NDC | 72189011405 |
| Package | 5 mL in 1 BOTTLE, PLASTIC (72189-114-05) |
| Marketing Start Date | 2020-06-25 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a8ee2e96-d09a-d0fe-e053-2a95a90a30b1 Details
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
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
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.
INSTRUCTIONS FOR USE
SPL UNCLASSIFIED SECTION
SPL UNCLASSIFIED SECTION
INGREDIENTS AND APPEARANCE
| KETOTIFEN FUMARATE
ketotifen fumarate solution |
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| KETOTIFEN FUMARATE
ketotifen fumarate solution/ drops |
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| Labeler - DIRECT RX (079254320) |
| Registrant - DIRECT RX (079254320) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| DIRECT RX | 079254320 | relabel(72189-114, 72189-212) | |