Vitacilina Anti Itch Hydrocortisone

Vitacilina Anti Itch Hydrocortisone by

Drug Labeling and Warnings

Vitacilina Anti Itch Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Taisho Pharmaceutical California Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

VITACILINA ANTI ITCH HYDROCORTISONE- hydrocortisone cream 
Taisho Pharmaceutical California Inc.

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Vitacilina Anti Itch Hydrocortisone

Drug Facts

Active ingredient (in each gram)

Hydrocortisone 1%

Purpose

Antipruritic (anti-itch)

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.

Warnings

For external use only.

Avoid contact with eyes

Do not use

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

When using this product

  • 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

  • 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,

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

  • 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

  • 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

  • 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:

Label

Inner Label0

VITACILINA ANTI ITCH HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 81929-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
ISOPROPYL ALCOHOL (UNII: ND2M416302)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
EDETATE TRISODIUM (UNII: 420IP921MB)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 81929-005-011 in 1 CARTON10/01/202410/02/2024
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01710/01/202410/02/2024
Labeler - Taisho Pharmaceutical California Inc. (603827635)

Revised: 2/2025
Document Id: 2d7c78dd-0379-7c51-e063-6294a90abecb
Set id: 60fa0ed9-aa38-477c-babc-4dcd80dfa1ca
Version: 3
Effective Time: 20250206