SPL v6
SPL
SPL Set ID bc97f364-9443-47b8-9c2d-b5dcc00cc9b7
Route
TOPICAL
Published
Effective Date 2018-05-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Aloe Vera Leaf Cetyl Alcohol Dimethicone Edetic Acid Ethylparaben Glycerin Glyceryl Monostearate Isohexadecane Maltodextrin Methyl Gluceth-20 Methylparaben Petrolatum Phenoxyethanol Polysorbate 80 Propylene Glycol Sodium Citrate Stearic Acid Tocopherol Water Ginger

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-05-25

Description

Active ingredients Hydrocortisone 1%


Medication Information

Warnings and Precautions

. Warnings. For external use only

•in the genital area if you have a vaginal Do not use

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 ssociated with minor skin

irritation, inflammation and rashesdue to:

•eczema      •psoriasis      •poison ivy, oak, sumac

•insect bites   •detergents   •jewelry

•cosmetics   •soaps   •seborrheic dermatitis

•temporarily relieves external anal and genital itching

•other uses of this product should be under advice and

supervision of a doctor

Dosage and Administration

Directions

• : for relieving of 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

• s: for external anal and genital itching, adult

•when practical, clean the affected area with mild soap

and warm water and 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 contract a Poison Control Center right away.

Section 51727-6

aloe barbadensis leaf juice, cetyl alcohol, Inactive ingredients

dimethicone, EDTA, ethylparaben, glycerin, glyceryl monostearate,

isohexadecane, maltodextrin, methyl gluceth-20, methyparaben, petrolatum,

phenoxyethanol, polysorbate 80, propylene glycol, sodium citrate, stearic

acid, tocopherol, water, zingiber officinale (ginger) root extract

Section 51945-4

Section 53413-1

1-800-639-3803  Weekdays 9 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 ssociated with minor skin

irritation, inflammation and rashesdue to:

•eczema      •psoriasis      •poison ivy, oak, sumac

•insect bites   •detergents   •jewelry

•cosmetics   •soaps   •seborrheic dermatitis

•temporarily relieves external anal and genital itching

•other uses of this product should be under advice and

supervision of a doctor

Dosage and Administration (34068-7)

Directions

• : for relieving of 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

• s: for external anal and genital itching, adult

•when practical, clean the affected area with mild soap

and warm water and 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

•in the genital area if you have a vaginal Do not use

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 contract a Poison Control Center right away.

Section 51727-6 (51727-6)

aloe barbadensis leaf juice, cetyl alcohol, Inactive ingredients

dimethicone, EDTA, ethylparaben, glycerin, glyceryl monostearate,

isohexadecane, maltodextrin, methyl gluceth-20, methyparaben, petrolatum,

phenoxyethanol, polysorbate 80, propylene glycol, sodium citrate, stearic

acid, tocopherol, water, zingiber officinale (ginger) root extract

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-800-639-3803  Weekdays 9 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

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