Vanicream™ Hc Anti-itch Cream

Drug Facts

Composition & Product

Active Ingredients

Hydrocortisone (1.12 g)

Inactive Ingredients

Petrolatum Cetostearyl Alcohol Sorbic Acid Polyoxyl 20 Cetostearyl Ether Peg-30 Stearate Propanediol Sorbitol Glyceryl Monostearate Water Silicon Dioxide Dimethicone

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2016-01-26 Until 2026-11-25

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and 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

Dosage and 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

Description

Active ingredient Hydrocortisone acetate 1.12% (equivalent to hydrocortisone 1%)

Section 42229-5

*To learn more about our products and ingredients, visit www.vanicream.com

facebook logo, instagram logo Official Vanicream

PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901

1-800-325-8232

Made in USA with select US and imported materials

GP24H

Section 44425-7

Other information

store at room temperature

Section 50565-1

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

Section 50566-9

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.

Section 50567-7

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

Section 50570-1

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.

Section 51727-6

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

Section 51945-4

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)

Section 53413-1

Questions?

1-800-325-8232

www.vanicream.com

Section 55105-1

Purpose

Anti-itch

Section 55106-9

Active ingredient

Hydrocortisone acetate 1.12%

(equivalent to hydrocortisone 1%)

Drug Facts

Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 42229-5 (42229-5)

*To learn more about our products and ingredients, visit www.vanicream.com

facebook logo, instagram logo Official Vanicream

PHARMACEUTICAL SPECIALTIES, INC.

ROCHESTER, MN 55901

1-800-325-8232

Made in USA with select US and imported materials

GP24H

Section 44425-7 (44425-7)

Other information

store at room temperature

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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.

Section 50567-7 (50567-7)

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

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

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)

Section 53413-1 (53413-1)

Questions?

1-800-325-8232

www.vanicream.com

Section 55105-1 (55105-1)

Purpose

Anti-itch

Section 55106-9 (55106-9)

Active ingredient

Hydrocortisone acetate 1.12%

(equivalent to hydrocortisone 1%)

Drug Facts

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "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", "34068-7": "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", "34071-1": "Warnings For external use only", "42229-5": "*To learn more about our products and ingredients, visit www.vanicream.com facebook logo, instagram logo Official Vanicream PHARMACEUTICAL SPECIALTIES, INC. ROCHESTER, MN 55901 1-800-325-8232 Made in USA with select US and imported materials GP24H", "44425-7": "Other information store at room temperature", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away", "50566-9": "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.", "50567-7": "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", "50570-1": "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.", "51727-6": "Inactive ingredients ceteareth-20, cetearyl alcohol, glyceryl stearate, PEG-30 stearate, petrolatum, propanediol, simethicone, sorbic acid, sorbitol, water", "51945-4": "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)", "53413-1": "Questions? 1-800-325-8232 www.vanicream.com", "55105-1": "Purpose Anti-itch", "55106-9": "Active ingredient Hydrocortisone acetate 1.12% (equivalent to hydrocortisone 1%)"}

Vanicream™ Hc Anti-itch Cream

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information