Indications and uses
. treats repeat vaginal yeast infections . relieves external itching and irritation due to a repeat vaginal yeast infection
. treats repeat vaginal yeast infections . relieves external itching and irritation due to a repeat vaginal yeast infection
. before using this product read the enclosed consumer information leaflet for complete instructions . adults and children 12 years of age and over: . applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row . external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated skin outside the vagina. Use daily for up to 7 days as neede...
Miconazole Nitrate 2% (100 mg in each applicator)
Vaginal antifungal
If swallowed, get medical help or contact a
Poison Control Center right away.
. treats repeat vaginal yeast infections
. relieves external itching and irritation due to a repeat vaginal yeast infection
For vaginal use only
Ask a doctor before use if you have
. never had a vaginal yeast infection diagnosed by a doctor
. 1 or more of the following:
abdominal pain, fever, chills, nausea, vomiting, foul-smelling vaginal discharge
. vaginal yeast infections often (such as once a month or 3 in 6 months)
. been exposed to the human immunodeficiency virus (HIV) that causes AIDS
Ask a doctor or pharmacist before use if you are taking the prescription
blood thinning medication warfarin, because bleeding or bruising may occur.
When using this product
. do not use tampons, douches, spermicides, or other vaginal products
. do not have vaginal intercourse
. condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs)
Stop use and ask a doctor if
. symptoms do not get better in 3 days
. symptoms last more than 7 days
. you get abdominal pain, fever, chills, nausea, vomiting, foul-smelling vaginal discharge, or rash
If pregnant or breast-feeding, ask a health professional before use.
. do not purchase if printed "Safety Sealed" carton
overwrap is broken or missing
. do not use if seal over tube opening has been punctured or cannot be seen
. store at room temperature 15°-30°C (59°-86°F), avoid heat over 30°C or 86°F.
. before using this product read the enclosed consumer
information leaflet for complete instructions
. adults and children 12 years of age and over:
. applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row
. external cream: squeeze a small amount of cream onto your fingertip.
Gently apply the cream onto the itchy, irritated skin outside the
vagina. Use daily for up to 7 days as needed
. children under 12 years of age: ask a doctor
benzoic acid, BHA, mineral oil, peglicol 5 oleate,
pegoxol 7 stearate, purified water
| Class | Version | Type | Effective |
|---|---|---|---|
| MICONAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| c6f86816-7da6-43ea-8c25-ac9758311cc5 | Product name | 1 | 20220118 |
| 252e11b6-1a9a-4283-a242-df2c129c496d | Product name | 3 | 20170717 |
| 3a55f4fb-5aec-4c88-0ff7-4d608ad4866a | Product name | 1 | 20140508 |
| 5b9a7965-36d2-8412-dcaf-f76a65411611 | Product name | 1 | 20140508 |
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 21695-854-45 | 2019-09-24 | C162847 | 48780-1 | 934fe258-4a5b-48b1-e053-8cdaa90a720a | Miconazole Nitrate 2% Drug Facts |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 21695-854-45 | Miconazole Nitrate | 45 g in 1 TUBE | CREAM | 45 | 1 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 21695-854-45 | GM - Gram | 21695-854 | e77b4ff1-c33f-44d8-9f49-67043c539919 | 1 | 2012-07-24 |
| 0713-0252-37 | GM - Gram | 0713-0252 | 4eef55c7-51cd-4f3e-aa0f-27909ec64d7b | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| MICONAZOLE NITRATE | ACTIVE INGREDIENT | VW4H1CYW1K | 1 | |
| MICONAZOLE | ACTIVE MOIETY | 7NNO0D7S5M | 1 | |
| BENZOIC ACID | INACTIVE INGREDIENT | 8SKN0B0MIM | 1 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | 1 | |
| MINERAL OIL | INACTIVE INGREDIENT | T5L8T28FGP | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 21695-854 | 21695-854-45 |
| 0713-0252 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MICONAZOLE NITRATE | VW4H1CYW1K | ACTIB |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| BUTYLATED HYDROXYANISOLE | REK4960K2U | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| WATER | 059QF0KO0R | IACT |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SUPPOSITORY / VAGINAL | 2 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | ELIXIR / ORAL | 90 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET / ORAL | 8 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SYRUP / ORAL | 20 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | CREAM / TOPICAL | 6 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE, EXTENDED RELEASE / ORAL | 120 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TRANSDERMAL | 6.09 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SOLUTION / ORAL | 5 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / TOPICAL | 82 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SYSTEM / TOPICAL | 654.36 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | AEROSOL, FOAM / TOPICAL | 1 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | OINTMENT / VAGINAL | 0.02 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / VAGINAL | 30 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS | NA | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | TABLET, COATED / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / VAGINAL | 402 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / OPHTHALMIC | 59.5 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, EXTENDED RELEASE / ORAL | NA | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SYRUP / ORAL | 1 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | FILM, EXTENDED RELEASE / TRANSDERMAL | 34 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET / SUBLINGUAL | 2 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SUSPENSION / RECTAL | 0.1 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SOAP / TOPICAL | 0.82 %w/w | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | INJECTION / INTRAVENOUS | 5 %w/v | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | GEL / TOPICAL | 0.1 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / OPHTHALMIC | 0.1 %w/w | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | CONCENTRATE / ORAL | 12.5 mg/5ml | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CREAM / VAGINAL | 0.03 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | GEL / TOPICAL | 2.5 %w/w | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SUSPENSION / ORAL | 15 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, FILM COATED / ORAL | NA | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, FILM COATED / ORAL | 0.4 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SOLUTION / IRRIGATION | 0.02 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | PASTE / DENTAL | 95 %w/w | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | LOTION / TOPICAL | NA | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | MOUTHWASH / BUCCAL | NA | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CAPSULE, LIQUID FILLED / ORAL | 4 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | INJECTION / INTRAMUSCULAR | 5 %w/v | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | OINTMENT / TOPICAL | 9938 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, CHEWABLE / ORAL | 6 mg | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | CREAM / VAGINAL | 10 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | GRANULE, FOR SUSPENSION / ORAL | NA | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SOLUTION / ORAL | 100 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SUPPOSITORY / VAGINAL | 1 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CREAM / TOPICAL | 2772 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | FILM / SUBLINGUAL | 0.08 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | SUSPENSION / ORAL | 2.5 mg/5ml | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | LIQUID / ORAL | 2 mg/1ml | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | TABLET, COATED / ORAL | 1.5 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | OINTMENT / TOPICAL | 0.01 %w/w | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | CAPSULE / ORAL | 120 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUSPENSION / AURICULAR (OTIC) | 0.5 %w/v | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION / INTRAVENOUS | NA | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CONCENTRATE / ORAL | 0.08 mg/1ml | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | SOLUTION / TOPICAL | 0.1 %w/w | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| BENZOIC ACID | BENZOIC ACID | 8SKN0B0MIM | TABLET, FILM COATED / ORAL | NA | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | LOTION / TOPICAL | 1428 mg | ||
| MINERAL OIL | MINERAL OIL | T5L8T28FGP | SUPPOSITORY / RECTAL | NA |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074366-001 | MICONAZOLE NITRATE | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 |
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074366-001 | MICONAZOLE NITRATE | 2% | CREAM / VAGINAL | 1996-02-22 | 3a93d1ddd44b… |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 6791d4f2-c485-4daf-82c7-0cafa9a7a17d | 6791d4f2-c485-4daf-82c7-0cafa9a7a17d | 2011-02-17 | Warnings | 6791d4f2-c485-4daf-82c7-0cafa9a7a17d 6791d4f2-c485-4daf-82c7-0cafa9a7a17d |
Adverse event summaries are temporarily unavailable. Other product information remains available.