SPL v2
SPL
SPL Set ID ea26265d-f24e-458e-8bf0-287b2d49f4f4
Route
TOPICAL
Published
Effective Date 2017-06-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Aloe Vera Leaf Cetostearyl Alcohol Edetate Disodium Glyceryl Monostearate Methylparaben Mineral Oil Polysorbate 60 Propylene Glycol Sorbitan Monostearate Water Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-06-18

Description

Active ingredients Hydrocortisone 1%


Medication Information

Warnings and Precautions

Warnings  For external use only.

: Do not use

•in the genital area if you have 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 told to do so by a doctor.

•do not put directly into rectum by using fingers or

any mechanical device or applicator.

Stop use and ask a doctor if

•condition worsens, 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 asked a doctor  •rectal bleeding occurs

Indications and Usage

Uses

•temporarily relieves itching associated with minor skin

irritations, inflammation and rashes due to:

   •eczema  •psoriasis  •poison ivy, oak, sumac

   •insect bites  •detergents  •jewelry

   •cosmetics  •soaps  •saborrheiic dermatitis

•temproarily relieves external and genital itching

•other uses of this product should be under advice and

supervision of a doctor

Dosage and Administration

Directions

•for itching or skin irritation, 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: ask a doctor

•for external and genital itching, adults:

   •when practical, clean the affected area with mild soap

   and warm waterand rinse thoroughly

   •gently dry by patting or blotting with toilet tissue or soft

   cloth before applying

   •apply to affected area not more than 3 to 4 times daily

   •children under 12 years of age: ask a doctor

Description

Active ingredients Hydrocortisone 1%

Section 44425-7

Other information

•store at room temperature 68° - 77° F (20° - 25° C)

Section 50565-1

. If swallowed, get medical Keep out of reach of children

help or contact a Poison Control Center right away.

Section 51727-6

aloe barbadensis leaf juice, Inactive ingredients

ceteastrearyl alcohol, edetate disodium, glyceryl

monostearate, methylparaben, mineral oil, polysorbate

60, propylene glycol, span 60, water, white petrolatum

Section 51945-4

Section 53413-1

1-800-638-3800  Weekdays 0 AM to 4 PM EST Questions? 

Section 55105-1

Purpose

Anti-itch

Section 55106-9

Active ingredients

Hydrocortisone 1%


Structured Label Content

Indications and Usage (34067-9)

Uses

•temporarily relieves itching associated with minor skin

irritations, inflammation and rashes due to:

   •eczema  •psoriasis  •poison ivy, oak, sumac

   •insect bites  •detergents  •jewelry

   •cosmetics  •soaps  •saborrheiic dermatitis

•temproarily relieves external and genital itching

•other uses of this product should be under advice and

supervision of a doctor

Dosage and Administration (34068-7)

Directions

•for itching or skin irritation, 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: ask a doctor

•for external and genital itching, adults:

   •when practical, clean the affected area with mild soap

   and warm waterand rinse thoroughly

   •gently dry by patting or blotting with toilet tissue or soft

   cloth before applying

   •apply to 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 the genital area if you have 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 told to do so by a doctor.

•do not put directly into rectum by using fingers or

any mechanical device or applicator.

Stop use and ask a doctor if

•condition worsens, 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 asked a doctor  •rectal bleeding occurs

Section 44425-7 (44425-7)

Other information

•store at room temperature 68° - 77° F (20° - 25° C)

Section 50565-1 (50565-1)

. If swallowed, get medical Keep out of reach of children

help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

aloe barbadensis leaf juice, Inactive ingredients

ceteastrearyl alcohol, edetate disodium, glyceryl

monostearate, methylparaben, mineral oil, polysorbate

60, propylene glycol, span 60, water, white petrolatum

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-800-638-3800  Weekdays 0 AM to 4 PM EST Questions? 

Section 55105-1 (55105-1)

Purpose

Anti-itch

Section 55106-9 (55106-9)

Active ingredients

Hydrocortisone 1%


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)