Vanicream Hc Anti-itch Cream
FDA Label NDC 45334-327
15 label sections · Submitted to the FDA by Pharmaceutical Specialties, Inc. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Pharmaceutical Specialties, Inc. for the product Vanicream Hc Anti-itch (NDC 45334-327). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredient
Hydrocortisone acetate 1.12%
(equivalent to hydrocortisone 1%)
Otc - Purpose
Purpose
Anti-itch
Indications & Usage
Uses
- for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:
- 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
· eczema · psoriasis · insect bites
· detergents · jewelry · seborrheic dermatitis
· soaps · cosmetics · poison ivy, oak, sumac
Warnings
Warnings
For external use only
Otc - 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.
Otc - 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
Otc - 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.
Otc - 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, simethicone, sorbic acid, sorbitol, water
Otc - Questions
Questions?
1-800-325-8232
www.vanicream.com
Other
*To learn more about our products and ingredients, visit www.vanicream.com
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PHARMACEUTICAL SPECIALTIES, INC.
ROCHESTER, MN 55901
1-800-325-8232
Made in USA with select US and imported materials
GP24H
Vanicream is a trademark, or registered trademark, of Pharmaceutical Specialties, Inc. in the U.S. or other countries.
© PSI 2015 All rights reserved
Package Label.Principal Display Panel
NDC 45334-327-02
DERMATOLOGIST TESTED
MAXIMUM STRENGTH
VANICREAM™ HC
1% Hydrocortisone Anti-Itch Cream
Non-comedogenic ● Gluten-Free
for Sensitive Kin
Net Wt 2 oz (57 g)
* Please review the disclaimer below.
