Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID bcc99e5a-2403-46da-9c9d-8411fa4104e0
Route
TOPICAL
Published
Effective Date 2013-03-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Aloe Vera Leaf Glycerin Glyceryl Monostearate Methylparaben Mineral Oil Petrolatum Propylparaben Sodium Lauryl Sulfate Stearyl Alcohol Water

Identifiers & Packaging

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

Description

  aloe barbadensis leaf extract, glycerin, glyceral stearate, methylparaben, mineral oil, petrolatum, propylparaben, sodium lauryl sulfate, stearyl alcohol, water Inactive Ingredients


Medication Information

Warnings and Precautions

Warnings for external use only





Indications and Usage

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

- eczema           -insect bites          -poison ivy

-poison oak      -poison sumac      -soaps

-jewelry            -detergents            -cosmetics

-psoriasis         -seborrheic dermatisis

-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 the affected areanot more than 3 to 4 times dailt

-for children udner 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 mroe than 3 to 4 times daily

-children under 12 years of age: ask a doctor

Description

  aloe barbadensis leaf extract, glycerin, glyceral stearate, methylparaben, mineral oil, petrolatum, propylparaben, sodium lauryl sulfate, stearyl alcohol, water Inactive Ingredients

Section 50565-1

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

Section 50566-9

Do not use

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

-for the treatment of diaper rash. Consult a doctor

Stop use and ask a doctor if

-symptoms last for more than 7 days

-the condition gets worse

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

-rectal bleeding occurs



Section 50567-7

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 51727-6

  aloe barbadensis leaf extract, glycerin, glyceral stearate, methylparaben, mineral oil, petrolatum, propylparaben, sodium lauryl sulfate, stearyl alcohol, water Inactive Ingredients

Section 51945-4

Section 55105-1

Purpose

Anti-itch

Section 55106-9

Active Ingredient

Hydrocortisone, USP 1%


Structured Label Content

Indications and Usage (34067-9)

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

- eczema           -insect bites          -poison ivy

-poison oak      -poison sumac      -soaps

-jewelry            -detergents            -cosmetics

-psoriasis         -seborrheic dermatisis

-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 the affected areanot more than 3 to 4 times dailt

-for children udner 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 mroe 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





Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Do not use

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

-for the treatment of diaper rash. Consult a doctor

Stop use and ask a doctor if

-symptoms last for more than 7 days

-the condition gets worse

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

-rectal bleeding occurs



Section 50567-7 (50567-7)

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 51727-6 (51727-6)

  aloe barbadensis leaf extract, glycerin, glyceral stearate, methylparaben, mineral oil, petrolatum, propylparaben, sodium lauryl sulfate, stearyl alcohol, water Inactive Ingredients

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Anti-itch

Section 55106-9 (55106-9)

Active Ingredient

Hydrocortisone, USP 1%


Advanced Ingredient Data


Raw Label Data

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