FDA.reportPublic FDA data

Anti-Itch Vulva Cream 1 Hydrocortisone Acetate

Manufacturer
The Honey Pot Company LLC
Effective date
2024-08-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:16:24

Label at a glance#

ProductAnti-Itch Vulva Cream 1 Hydrocortisone Acetate
Active ingredientHYDROCORTISONE ACETATE
Label structure7 sections

Indications and uses

For the temporary relief of external feminine itching.

Dosage and administration

Apply to affected area not more than 3 to 4 times daily. Adults and children 12 years of age and older: Children under 12 years of age: Consult a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone Acetate 1%

Purpose

OTC - PURPOSE SECTION

Anti-Itch

Uses:

INDICATIONS & USAGE SECTION

For the temporary relief of external feminine itching.

Warnings:

WARNINGS SECTION

For external use only

When using this product:

OTC - WHEN USING SECTION

avoid contact with eyes.

Stop use and ask doctor if:

OTC - STOP USE SECTION

  • Condition worsens
  • If symptoms persist for more than 7 days, or clear up and reoccur again within a few days

Do not use if:

OTC - DO NOT USE SECTION

you have vaginal discharge. Consult a physician.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions:

DOSAGE & ADMINISTRATION SECTION

Apply to affected area not more than 3 to 4 times daily. Adults and children 12 years of age and older: Children under 12 years of age: Consult a doctor

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Adansonia Digitata Seed Oil, Allantoin, Aloe Barbadensis Leaf Juice, Butyrospermum Parkii (Shea) Butter, C10-18 Triglycerides, Candelilla/Jojoba/Rice Bran Polyglyceryl-3 Esters, Caprylhydroxamic Acid, Caprylyl Glyceryl Ether, Ceramide NG, Cetearyl Alcohol, Cetyl Alcohol, Cholesterol, Citric Acid, Cocos Nucifera (Coconut) Oil, Ethoxydiglycol, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Helianthus Annuus (Sunflower) Seed Wax, Hydroxyethylcellulose, Lavandula Angustifolia (Lavender) Oil, Limonene, Linalool, Melia Azadirachta Seed Oil, Mentha Piperita (Peppermint) Oil, Myristyl Alcohol, Polyhydroxystearic Acid, Potassium Sorbate, Propanediol, Propolis Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Benzoate, Sodium Phytate, Sodium Stearoyl Lactylate, Steareth-30, Stearic Acid, Steary Alcohol, Sucrose Palmitate, Theobroma Cacao (Cocoa) Seed Butter, Water, Xanthan Gum

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

inner_labekinner_labek

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1039349hydrocortisone acetate 1 % Vaginal CreamPSN3
1039349hydrocortisone acetate 10 MG/ML Vaginal CreamSCD3
1039349hydrocortisone acetate 1 % Vaginal CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
HYDROCORTISONE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82637-9455-1Anti-Itch Vulva Cream 1 Hydrocortisone Acetate30 mL in 1 TUBECREAM303
82637-9455-1Anti-Itch Vulva Cream 1 Hydrocortisone Acetate1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82637-9455ANTI-ITCH VULVA CREAM 1 HYDROCORTISONE ACETATE (HYDROCORTISONE ACETATE) CREAM [THE HONEY POT COMPANY LLC]3Current NDC, Legacy NDC, 2 package rows20240802_6f32b536-6ebf-49a8-abb6-2a1daae2f6d7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82637-945582637-9455-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROXYETHYL CELLULOSE, UNSPECIFIEDT4V6TWG28DIACT
LAVENDER OILZBP1YXW0H8IACT
LIMONENE, (+)-GFD7C86Q1WIACT
LINALOOL, (+/-)-D81QY6I88EIACT
AZADIRACHTA INDICA SEED OIL4DKJ9B3K2TIACT
PEPPERMINT OILAV092KU4JHIACT
MYRISTYL ALCOHOLV42034O9PUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPANEDIOL5965N8W85TIACT
PROPOLIS WAX6Y8XYV2NOFIACT
JOJOBA OIL724GKU717MIACT
SODIUM BENZOATEOJ245FE5EUIACT
PHYTATE SODIUM88496G1ERLIACT
SODIUM STEAROYL LACTYLATEIN99IT31LNIACT
STEARETH-305776GCL1DGIACT
STEARIC ACID4ELV7Z65APIACT
STEARYL ALCOHOL2KR89I4H1YIACT
SUCROSE PALMITATE3OSQ643ZK5IACT
COCOA BUTTER512OYT1CRRIACT
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
ADANSONIA DIGITATA SEED OIL77MKL7AR5IIACT
ALLANTOIN344S277G0ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
SHEA BUTTERK49155WL9YIACT
C10-18 TRIGLYCERIDES43AGM4PHPIIACT
CANDELILLA WAXWL0328HX19IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CAPRYLYL GLYCERYL ETHERMI97BW74XZIACT
CERAMIDE NGC04977SRJ5IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CETYL ALCOHOL936JST6JCNIACT
CHOLESTEROL97C5T2UQ7JIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCONUT OILQ9L0O73W7LIACT
DIETHYLENE GLYCOL MONOETHYL ETHERA1A1I8X02BIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SUNFLOWER OIL3W1JG795YIIACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
HYDROCORTISONE ACETATE3X7931PO74ACTIB

Source Document#

Source XML

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-Itch Vulva Cream 1 Hydrocortisone AcetateHYDROCORTISONE ACETATEThe Honey Pot Company LLC6f32b536-6ebf-49a8-abb6-2a1daae2f6d72024-08-01WarningsExact identifier
ndc (package): 82637-9455-1
ndc (product): 82637-9455
ndc11 (package): 82637945501
spl id: 1ea12af8-cc63-6bfa-e063-6294a90a3302
spl set id: 6f32b536-6ebf-49a8-abb6-2a1daae2f6d7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.