Indications and uses
treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
Clotrimazole Vaginal Cream, USP
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2021-02-17
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 22:51:39
Label at a glance#
ProductClotrimazole
Active ingredientCLOTRIMAZOLE
Label structure11 sections
Dosage and administration
before using this product, read the enclosed educational brochure for complete directions and information adults and children 12 years of age and over: vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use. external cream: use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of ...
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredients
Clotrimazole, USP 1% (50 mg in each applicatorful)
Active ingredients
Clotrimazole, USP 1% (external cream)
Purpose
Vaginal antifungal
Purpose
Vaginal antifungal
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
Warnings
For vaginal use only
Do not use
if you have never had a vaginal yeast infection diagnosed by a doctor
Ask a doctor before use if you have
- vaginal itching and discomfort for the first time
- lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. You may have a more serious condition.
- vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant, or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
- been exposed to the human immunodeficiency virus (HIV) that causes AIDS
When using this product
- do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
- do not have vaginal intercourse
- mild increase in vaginal burning, itching or irritation may occur
- if you do not get complete relief, ask a doctor before using another product
Stop use and ask a doctor if
- symptoms do not get better in 3 days
- symptoms last more than 7 days.
- you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or a foul-smelling vaginal discharge
If pregnant or breast-feeding,
ask a health professional before use.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
- before using this product, read the enclosed educational brochure for complete directions and information
- adults and children 12 years of age and over:
- vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use.
- external cream: use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days as needed.
- children under 12 years of age: ask a doctor
Other information
- store at room temperature between 2° and 30°C (36° to 86°F)
- see end flaps of carton and tube for lot number and expiration date
- Tamper-evident: Safety sealed: the tube opening should be sealed. If seal has been punctured or is not visible, do not use the product.
Inactive ingredients
benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate
Questions?
1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.
Principal Display Panel
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-4800-4 | 2024-06-30 | C162847 | 48780-1 | f386c64a-4056-0266-e053-dadaa90a7c1a | Clotrimazole Vaginal Cream, USP |
| 68071-4800-4 | 2023-01-30 | C162847 | 48780-1 | f386c64a-4056-0266-e053-dadaa90a7c1a | Clotrimazole Vaginal Cream, USP |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0472-0220-41 | GM - Gram | 0472-0220 | 07c8e601-9256-4d0a-bff4-b0a7cb96e84b | 1 | 2013-02-13 |
| 0472-0220-63 | GM - Gram | 0472-0220 | 3567f43b-d2ca-419c-8eda-b9b25afb243b | 1 | 2013-02-13 |
Products#
Every source-derived product name is available through these pages.
- Clotrimazole
- BENZYL ALCOHOL
- CETOSTEARYL ALCOHOL
- CETYL ESTERS WAX
- OCTYLDODECANOL
- POLYSORBATE 60
- WATER
- SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
- SORBITAN MONOSTEARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68071-4800 | 68071-4800-4 |
| 0472-0220 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BENZYL ALCOHOL | LKG8494WBH | IACT |
| CETOSTEARYL ALCOHOL | 2DMT128M1S | IACT |
| CETYL ESTERS WAX | D072FFP9GU | IACT |
| OCTYLDODECANOL | 461N1O614Y | IACT |
| POLYSORBATE 60 | CAL22UVI4M | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | 593YOG76RN | IACT |
| SORBITAN MONOSTEARATE | NVZ4I0H58X | IACT |
| CLOTRIMAZOLE | G07GZ97H65 | ACTIB |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A074165-001 | CLOTRIMAZOLE | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 |
Observed Orange Book product history#
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A074165-001 | CLOTRIMAZOLE | 1% | CREAM / VAGINAL | RS | 1993-07-16 | f41ea6bd6efb… |
openFDA label cross-check#
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 |
|---|---|---|---|---|---|---|
| 1adc5d7a-317f-d758-e063-6394a90afaca | 83e7f7a3-1f9e-694f-e053-2a91aa0a43f2 | 2024-06-14 | Warnings | 83e7f7a3-1f9e-694f-e053-2a91aa0a43f2 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.