FDA Label for Vanicream Hc Anti-itch
View Indications, Usage & Precautions
Vanicream Hc Anti-itch Product Label
The following document was submitted to the FDA by the labeler of this product Pharmaceutical Specialties, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
For information on our other products for sensitive skin, visit our website at www.vanicream.com or call 1-800-325-8232
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PHARMACEUTICAL SPECIALTIES, INC.
ROCHESTER, MN 55901
Made in U.S.A.
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
Vanicream is a trademark, or registered trademark, of Pharmaceutical Specialties, Inc. in the U.S. or other countries.
© PSI 2015 All rights reserved
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, purified water, simethicone, sorbic acid, sorbitol
Otc - Questions
Questions?
1-800-325-8232
www.vanicream.com
Package Label.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)
* Please review the disclaimer below.