Indications and uses
treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
Clotrimazole
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2022-01-07
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 23:48:17
Label at a glance#
ProductClotrimazole
Active ingredientCLOTRIMAZOLE
Label structure10 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 ...
Storage and handling
to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use do not use if foil seal on tube opening is broken or missing do not purchase if carton is open store at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F) before using any medication, read all label directions. Keep carton, it contains important information.
Contacts and useful links#
Websitewww.h2-pharma.com
www.h2-pharma.com
www.h2-pharma.comLabel contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
OTC - PURPOSE SECTION
| Active ingredients | Purpose |
|---|---|
| Clotrimazole USP, 1% (50 mg in each applicatorful) | Vaginal antifungal |
| Clotrimazole USP, 1% (external cream) | Vaginal antifungal |
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a vaginal yeast infection
Warnings
SPL UNCLASSIFIED SECTION
For vaginal use only.
OTC - DO NOT USE SECTION
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
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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
- to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
- do not use if foil seal on tube opening is broken or missing
- do not purchase if carton is open
- store at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F)
- before using any medication, read all label directions. Keep carton, it contains important information.
Inactive ingredients
benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate
Questions?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
SPL UNCLASSIFIED SECTION
Distributed by:
H2-Pharma, LLC
Montgomery, AL 36117
www.h2-pharma.com
PRINCIPAL DISPLAY PANEL
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| CLOTRIMAZOLE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b64d2752-34ef-378a-1f4f-8bff32b0d1ae | Product name | 4 | 20250626 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| cb7783e0-feaa-7e56-fb3b-d43b6efa77c9 | Product name | 2 | 20250121 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
| f5395dd2-4395-d8c6-3477-8c2d4a2f951c | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 68071-2614-4 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-5b8e-d83d-e063-dadaa90ab31f | Clotrimazole |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68071-2614-4 | Clotrimazole | 45 g in 1 TUBE, WITH APPLICATOR | CREAM | 45 | 1 | |
| 68071-2614-4 | Clotrimazole | 1 in 1 CARTON | CREAM | 1 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68071-2614 | CLOTRIMAZOLE CREAM [NUCARE PHARMACEUTICALS,INC.] | 1 | Legacy NDC, 2 package rows | 20220217_d505c338-ddbe-26eb-e053-2a95a90a0261.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61269-220-41 | GM - Gram | 61269-220 | 0830b94c-a7bf-4be1-b0d0-c463f1cc4446 | 1 | 2021-07-15 |
| 61269-220-63 | GM - Gram | 61269-220 | fb2d6f46-aa3c-4840-9e8c-75f28d27d9ac | 1 | 2021-07-15 |
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 |
|---|---|
| 68071-2614 | 68071-2614-4 |
| 61269-220 |
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 |
|---|---|---|---|---|---|---|
| Clotrimazole | CLOTRIMAZOLE | H2-Pharma, LLC | 388f7e35-efbe-496b-a8d6-518caa22328d | 2023-01-11 | Warnings | 61269-220 |
| d505c338-ddbf-26eb-e053-2a95a90a0261 | d505c338-ddbe-26eb-e053-2a95a90a0261 | 2022-01-07 | Warnings | d505c338-ddbf-26eb-e053-2a95a90a0261 d505c338-ddbe-26eb-e053-2a95a90a0261 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.