FDA.reportPublic FDA data

Vitacilina Anti Itch Hydrocortisone

Manufacturer
Taisho Pharmaceutical California Inc.
Effective date
2024-08-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:53:50

Label at a glance#

ProductVitacilina Anti Itch Hydrocortisone
Active ingredientHYDROCORTISONE
Label structure7 sections

Indications and uses

for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry and for external anal and genital itching.

Dosage and administration

for itching of skin irritation, inflammation, and rashes:  Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily Children under 2 years of age: consult a doctor For external anal and genital itching: Adults and children 12 years of age and older: when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly by patting or blotting with an...

Label contents#

Full prescribing information#

Active ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Antipruritic (anti-itch)

Uses

INDICATIONS & USAGE SECTION

  • for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry
  • and for external anal and genital itching.

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes

Do not use

OTC - DO NOT USE SECTION

  • if you have a vaginal discharge. Consult a doctor.

When using this product

OTC - WHEN USING SECTION

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • bleeding occurs
  • symptoms persist for more than 7 days or clear up and occurs again within a few days.

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • for itching of skin irritation, inflammation, and rashes: 

Adults and children 2 years of age and older:


  • apply to affected area not more than 3 to 4 times daily
    Children under 2 years of age:consult a doctor
    For external anal and genital itching:
    Adults and children 12 years of age and older:
  • when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly by patting or blotting with an appropriate cleansing pad
  • gently dy by patting or blotting with toilet tissue or a soft cloth before appliction of this product
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age:consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident:DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

  • aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Inner Label0Inner Label0

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81929-00581929-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CETYL ALCOHOL936JST6JCNIACT
DMDM HYDANTOINBYR0546TOWIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOPROPYL ALCOHOLND2M416302IACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
EDETATE TRISODIUM420IP921MBIACT
HYDROCORTISONEWI4X0X7BPJACTIB

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
2d7c78dd-0379-7c51-e063-6294a90abecb60fa0ed9-aa38-477c-babc-4dcd80dfa1ca2025-02-06WarningsExact identifier
spl set id: 60fa0ed9-aa38-477c-babc-4dcd80dfa1ca

Reported adverse events (FAERS/openFDA)#

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