Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID cddc9c4a-7c58-4225-921a-05d6afb49178
Route
TOPICAL
Published
Effective Date 2013-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-03-01

Description

Inactive Ingredients   white petrolatum


Medication Information

Warnings and Precautions

Warnings

For external use only.

Do not use

-in genital area if you have a vaginal discharge. Consult a doctor.

-for the treatment of diaper rash, Consult a doctor.

When using this product

-avoid contact with eyes

-do not use more than directed unless directed by a doctor

-do not put this product into the rectum by using fingers or any other mechanical device or applicator

Indications and Usage

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

-eczema   -insect bites   -poison ivy

-poison oak   -poison sumac   -soaps

-jewelry   -detergents   -cosmetics

-psoriasis   -seborrheic dermatitis

-for external genital, feminine 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 of skin irritation, inflammation and rashes:

-adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times daily

-for children under 2 years of age: ask a doctor

for external anal and genital itching:

adults:

-clean the affected area with mild soap and warm water and rinse clean.

-dry the affected area before applying

-apply to the affected area not more than 3 to 4 times daily

-children under 12 years of age: ask a doctor

Description

Inactive Ingredients   white petrolatum

Section 44425-7

Other Information store at room temperature 68-77 F (20-25 C)

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

-symptoms last for more than 7 days

-the conditions get worse

-symptoms clear up and then occur again within a few days

-rectal bleeding occurs

Section 51727-6

Inactive Ingredients   white petrolatum

Section 51945-4

Section 53413-1

Questions? 1-800-639-3803 Weekdays 9AM to 4 PM EST

Section 55105-1

Purpose

Anti-itch

Section 55106-9

Active Ingredient

Hydrocortisone, USP 1%


Structured Label Content

Indications and Usage (34067-9)

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

-eczema   -insect bites   -poison ivy

-poison oak   -poison sumac   -soaps

-jewelry   -detergents   -cosmetics

-psoriasis   -seborrheic dermatitis

-for external genital, feminine 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 of skin irritation, inflammation and rashes:

-adults and children 2 years of age and older: apply to affected area not more than 3 or 4 times daily

-for children under 2 years of age: ask a doctor

for external anal and genital itching:

adults:

-clean the affected area with mild soap and warm water and rinse clean.

-dry the affected area before applying

-apply to the affected area not more than 3 to 4 times daily

-children under 12 years of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only.

Do not use

-in genital area if you have a vaginal discharge. Consult a doctor.

-for the treatment of diaper rash, Consult a doctor.

When using this product

-avoid contact with eyes

-do not use more than directed unless directed by a doctor

-do not put this product into the rectum by using fingers or any other mechanical device or applicator

Section 44425-7 (44425-7)

Other Information store at room temperature 68-77 F (20-25 C)

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

-symptoms last for more than 7 days

-the conditions get worse

-symptoms clear up and then occur again within a few days

-rectal bleeding occurs

Section 51727-6 (51727-6)

Inactive Ingredients   white petrolatum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions? 1-800-639-3803 Weekdays 9AM to 4 PM EST

Section 55105-1 (55105-1)

Purpose

Anti-itch

Section 55106-9 (55106-9)

Active Ingredient

Hydrocortisone, USP 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)