Dosage and administration
adults and children 12 years and older Apply to external vaginal area not more than 3 to 4 times a day children under 12 years consult a doctor
Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula
- Manufacturer
- Combe Incorporated
- Effective date
- 2020-04-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-05-31 23:07:03
Label at a glance#
ProductVagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula
Active ingredientHYDROCORTISONE ACETATE
Label structure8 sections
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Vagisil Sensitive Skin Anti-Itch Creme
Drug Facts
Active ingredients
Hydrocortisone Acetate 1%
Purpose
Anti-itch
Use
For temporary external feminine itching.
Warnings
For external use only
Avoid contact with eyes
Stop use and ask a doctor if
condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days.
Do not use if
you have a vaginal discharge. Consult a physician.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
| adults and children 12 years and older | Apply to external vaginal area not more than 3 to 4 times a day |
| children under 12 years | consult a doctor |
Inactive ingredients:
water, cetyl ethylhexanoate, glycerin, PEG-40 hydrogenated castor oil, glyceryl dilaurate, dimethicone, colloidal oatmeal, aloe barbadensis leaf extract, sodium polyacrylate, caprylyl glycol, ceteareth-20, glyceryl oleate, acrylates/C10-30 alkyl acrylate crosspolymer, cyclopentasiloxane, trideceth-6, sodium hydroxide, disodium EDTA, sorbic acid, PEG/PPG-18/18 dimethicone, tocopheryl acetate, maltodextrin, phenoxyethanol.
PRINCIPAL DISPLAY PANEL
Vagisil Sensitive Skin Anti-Itch Creme, 1% Hydrocortisone
Net. Wt. 1 oz. (28 g)
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 1039349 | hydrocortisone acetate 1 % Vaginal Cream | PSN | 3 |
| 1039353 | Vagisil Satin 1 % Vaginal Cream | PSN | 3 |
| 1039353 | hydrocortisone acetate 10 MG/ML Vaginal Cream [Vagisil Satin] | SBD | 3 |
| 1039349 | hydrocortisone acetate 10 MG/ML Vaginal Cream | SCD | 3 |
| 1039349 | hydrocortisone acetate 1 % Vaginal Cream | SY | 3 |
| 1039353 | Vagisil Satin 1 % Vaginal Cream | SY | 3 |
| 1039353 | Vagisil Satin 10 MG/ML Vaginal Cream | SY | 3 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11509-5101-1 | 2020-04-20 | C162847 | 48780-1 | 9d75b9cf-e585-f424-e053-dadaa90a57ce | Vagisil Anti-Itch Crème Maximum Strength, Sensitive Skin Formula |
| 11509-5101-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-e585-f424-e053-dadaa90a57ce | Vagisil Anti-Itch Crème Maximum Strength, Sensitive Skin Formula |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11509-5101-1 | Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula | 28 g in 1 CARTON | CREAM | 28 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11509-5101 | VAGISIL ANTI-ITCH CREME MAXIMUM STRENGTH SENSITIVE SKIN FORMULA (HYDROCORTISONE ACETATE) CREAM [COMBE INCORPORATED] | 3 | Current NDC, Legacy NDC, 1 package rows | 20200421_9b69fa24-02dd-43e4-a81f-9a37968d7099.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 11509-5101-1 | GM - Gram | 11509-5101 | 4aee3eac-9efd-4774-8599-2423ca228886 | 1 | 2022-06-06 |
Products#
Every source-derived product name is available through these pages.
- Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula
- Hydrocortisone Acetate
- HYDROCORTISONE
- WATER
- CETYL ETHYLHEXANOATE
- GLYCERIN
- POLYOXYL 40 HYDROGENATED CASTOR OIL
- GLYCERYL DILAURATE
- DIMETHICONE
- OATMEAL
- ALOE VERA LEAF
- SODIUM POLYACRYLATE (2500000 MW)
- CAPRYLYL GLYCOL
- POLYOXYL 20 CETOSTEARYL ETHER
- GLYCERYL OLEATE
- CARBOMER INTERPOLYMER TYPE A (55000 CPS)
- CYCLOMETHICONE 5
- TRIDECETH-6
- SODIUM HYDROXIDE
- EDETATE DISODIUM
- SORBIC ACID
- PEG/PPG-18/18 DIMETHICONE
- ALPHA-TOCOPHEROL ACETATE
- MALTODEXTRIN
- PHENOXYETHANOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 11509-5101 | 11509-5101-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin Formula | HYDROCORTISONE ACETATE | Combe Incorporated | 9b69fa24-02dd-43e4-a81f-9a37968d7099 | 2024-12-12 | Warnings | 11509-5101-1 11509-5101 11509510101 9b69fa24-02dd-43e4-a81f-9a37968d7099 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.