VANICREAM HC ANTI-ITCH- hydrocortisone cream 
Pharmaceutical Specialties, Inc.

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VANICREAM™ HC Anti-Itch Cream

Drug Facts

Active ingredient

Hydrocortisone acetate 1.12%

(equivalent to hydrocortisone 1%)

Purpose

Anti-itch

Uses

· eczema · psoriasis · insect bites

· detergents · jewelry · seborrheic dermatitis

· soaps · cosmetics · poison ivy, oak, sumac

Warnings

For external use only

Do not use

When using this product

Stop use and ask a doctor if

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Directions

Other information

Inactive ingredients ceteareth-20, cetearyl alcohol, glyceryl stearate, PEG-30 stearate, petrolatum, propanediol, purified water, simethicone, sorbic acid, sorbitol

Questions?

1-800-325-8232

www.vanicream.com

*To learn more about our products and ingredients, visit www.vanicream.com or call 1-800-325-8232

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PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901

Made in U.S.A.

GP21O

Vanicream is a trademark, or registered trademark, of Pharmaceutical Specialties, Inc. in the U.S. or other countries.

© PSI 2015 All rights reserved

NDC 45334-327-02

DERMATOLOGIST TESTED

MAXIMUM STRENGTH

VANICREAM™ HC

1% Hydrocortisone Anti-Itch Cream

for Sensitive Skin

Free of dyes, fragrance, masking fragrance, lanolin, parabens & formaldehyde releasers

Non-comedogenic ● Gluten-Free

Fast relief for flare-ups due to

Net Wt 2 oz (57 g)

label

VANICREAM HC ANTI-ITCH 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:45334-327
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1.12 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
SORBIC ACID (UNII: X045WJ989B)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
PEG-30 STEARATE (UNII: 1U8KB35S20)  
PROPANEDIOL (UNII: 5965N8W85T)  
SORBITOL (UNII: 506T60A25R)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:45334-327-021 in 1 CARTON01/26/2016
157 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:45334-327-044 g in 1 TUBE; Type 0: Not a Combination Product02/09/201601/31/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01701/26/2016
Labeler - Pharmaceutical Specialties, Inc. (076499557)
Establishment
NameAddressID/FEIBusiness Operations
Pharmaceutical Specialties, Inc.076499557manufacture(45334-327) , pack(45334-327) , label(45334-327)

Revised: 10/2023
Document Id: 08679c4b-6af2-149c-e063-6294a90a1b40
Set id: 28b06507-27a5-2cb1-e054-00144ff8d46c
Version: 6
Effective Time: 20231023
 
Pharmaceutical Specialties, Inc.