1% Hydrocortisone Itch Cream

1% Hydrocortisone Itch Cream
SPL v1
SPL
SPL Set ID 1f95757d-a434-f02a-e063-6294a90a2d12
Route
TOPICAL
Published
Effective Date 2024-03-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Glycerin Glyceryl Monostearate Methylparaben Petrolatum Polysorbate 80 Propylparaben Propylene Glycol Water Anhydrous Trisodium Citrate Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-01

Description

Uses: for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes


Medication Information

Warnings and Precautions

Warnings :

For external use only Do not use for the treatment of diaper rash

Consult a doctor:before use if you have a vaginal discharge (for external feminine itching):

for external itching, do not exceed the recommended daily dosage or if bleeding occurs

if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

When using this product:avoid contact with eyes, do not put this product into rectum by using fingers or any mechanical



Do not use:with any other Hydrocortison product unless you have consulted a doctor

Indications and Usage

Uses:

for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema,

insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and

scrapes

Dosage and Administration

dIRECTIONS:  fOR ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER-APPLY TO AFFECTED AREA NOT MORE THAN 3 OR 4 TIMES DAILY

CHILDREN UNDER 2 YEARS, DO NOT USE, CONSULT A DOCTOR. ADULTS FOR EXTERNAL ANAL ITCHING WHEN PRACTICAL-CLEANSE THE AFFECTED AREA WITH A MILD SOAP AND WARM WATER AND RINCE THOROUGHLY OR BY PATTING AND BLOTTING WITH AN APPROPRIATE CLEANSING PAD. GENTLY DRY BY PATTING OR BLOTTING WITH A SOFT CLOTH BEFORE APPLICATION OF THIS PRODUCT.  CHILDREN UNDER 12 YEARS OF AGE-FOR EXTERNAL ANAL ITCHING, CONSULT A DOCTOR

Description

Uses: for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and scrapes

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. iF SWALLOWED, get medical help or

contact a Poison Control Center right

away.

Section 51727-6

INACTIVE INGREDIENTS:CITRIC acid, glycerin, glycerol stearate, methyl paraben, petrolatum, polysorbat 80, propyl

paraben, propylene glycol, purified water, sodium citrate, and titanium dioxide.

Section 55105-1

ANTIPRURITIC (ANTI-ITCH)

Section 55106-9

ACTIVE INGREDIENT (IN EACH GRAM)-HYDROCORTISONE 10 MG

1% Hydrocortisone Itch Cream


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,

insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis and

scrapes

Dosage and Administration (34068-7)

dIRECTIONS:  fOR ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER-APPLY TO AFFECTED AREA NOT MORE THAN 3 OR 4 TIMES DAILY

CHILDREN UNDER 2 YEARS, DO NOT USE, CONSULT A DOCTOR. ADULTS FOR EXTERNAL ANAL ITCHING WHEN PRACTICAL-CLEANSE THE AFFECTED AREA WITH A MILD SOAP AND WARM WATER AND RINCE THOROUGHLY OR BY PATTING AND BLOTTING WITH AN APPROPRIATE CLEANSING PAD. GENTLY DRY BY PATTING OR BLOTTING WITH A SOFT CLOTH BEFORE APPLICATION OF THIS PRODUCT.  CHILDREN UNDER 12 YEARS OF AGE-FOR EXTERNAL ANAL ITCHING, CONSULT A DOCTOR

Warnings and Precautions (34071-1)

Warnings :

For external use only Do not use for the treatment of diaper rash

Consult a doctor:before use if you have a vaginal discharge (for external feminine itching):

for external itching, do not exceed the recommended daily dosage or if bleeding occurs

if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days

When using this product:avoid contact with eyes, do not put this product into rectum by using fingers or any mechanical



Do not use:with any other Hydrocortison product unless you have consulted a doctor

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 51727-6 (51727-6)

INACTIVE INGREDIENTS:CITRIC acid, glycerin, glycerol stearate, methyl paraben, petrolatum, polysorbat 80, propyl

paraben, propylene glycol, purified water, sodium citrate, and titanium dioxide.

Section 55105-1 (55105-1)

ANTIPRURITIC (ANTI-ITCH)

Section 55106-9 (55106-9)

ACTIVE INGREDIENT (IN EACH GRAM)-HYDROCORTISONE 10 MG

1% Hydrocortisone Itch Cream


Advanced Ingredient Data


Raw Label Data

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