VANICREAM HC ANTI-ITCH- hydrocortisone cream

Vanicream HC Anti-Itch by

Drug Labeling and Warnings

Vanicream HC Anti-Itch by is a Otc medication manufactured, distributed, or labeled by Pharmaceutical Specialties, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredient

Hydrocortisone acetate 1.12%

(equivalent to hydrocortisone 1%)

PURPOSE

Purpose

Anti-itch

INDICATIONS & USAGE

Uses

• for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:

· eczema · psoriasis · insect bites

· detergents · jewelry · seborrheic dermatitis

· soaps · cosmetics · poison ivy, oak, sumac

• for the temporary relief of external genital and anal itching
• other uses of this product should be only under the advice and supervision of a doctor

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use

• in the genital area if you have a vaginal discharge. Consult a doctor.
• for the treatment of diaper rash. Consult a doctor.

WHEN USING

When using this product

• avoid contact with the eyes
• do not exceed the recommended daily dosage unless directed by a doctor
• do not put this product into the rectum by using fingers or any mechanical device or applicator

STOP USE

Stop use and ask a doctor if

• condition worsens
• rectal bleeding occurs
• symptoms persist for more than 7 days or clear up and occur again within a few days and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Directions

• for itching due to minor skin irritations, 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: Do not use, consult a doctor.

• for external anal and genital itching, adults:
• when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
• apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: consult a doctor

STORAGE AND HANDLING

Other information

• store at room temperature

INACTIVE INGREDIENT

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

QUESTIONS

Questions?

1-800-325-8232

www.vanicream.com

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For information on our other products for sensitive skin, visit our website at www.vanicream.com or call 1-800-325-8232

facebook.com/Official Vanicream

PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901

Made in U.S.A.

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Effective relief from itching associated with minor skin irritations, inflammation, and rashes due to:

• eczema
• seborrheic dermatitis
• psoriasis
• jewelry
• detergents
• insect bites
• soaps
• cosmetics
• poison ivy, oak, sumac

For sensitive skin. Free of dyes, fragrance, masking fragrance, lanolin, parabens, and formaldehyde.

non-comedogenic

non-greasy

easy to spread

gluten-free

Kid Friendly

SPL UNCLASSIFIED SECTION

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

© PSI 2015 All rights reserved

PRINCIPAL DISPLAY PANEL

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

Fast relief for flare-ups due to

• eczema
• dermatitis
• psoriasis

Net Wt 2 oz (57 g)

INGREDIENTS AND APPEARANCE

VANICREAM HC ANTI-ITCH 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 45334-327
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	1.12 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PETROLATUM (UNII: 4T6H12BN9U)
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 45334-327-02	1 in 1 CARTON	01/26/2016
1		57 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 45334-327-04	4 g in 1 TUBE; Type 0: Not a Combination Product	02/09/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/26/2016

Labeler - Pharmaceutical Specialties, Inc. (076499557)

Establishment
Name	Address	ID/FEI	Business Operations
Pharmaceutical Specialties, Inc.		076499557	manufacture(45334-327) , pack(45334-327) , label(45334-327)