PREPARATION H HYDROCORTISONE- hydrocortisone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

Haleon US Holdings LLC

INN (International Name):

hydrocortisone

Composition:

hydrocortisone 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anti-itch - temporary relief of external anal itching - temporary relief of itching associated with minor skin irritations and rashes - other uses of this product should be only under the advice and supervision of a doctor

Authorization status:

OTC monograph not final

Summary of Product characteristics

PREPARATION H HYDROCORTISONE- HYDROCORTISONE CREAM
HALEON US HOLDINGS LLC
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_DRUG FACTS_
_ACTIVE INGREDIENT_
Hydrocortisone 1%
_PURPOSE_
Anti-itch
_USES_
temporary relief of external anal itching
temporary relief of itching associated with minor skin irritations and
rashes
other uses of this product should be only under the advice and
supervision of a
doctor
_WARNINGS_
FOR EXTERNAL USE ONLY
DO NOT USE
for the treatment of diaper rash. Consult a doctor.
WHEN USING THIS PRODUCT
avoid contact with the eyes
do not exceed the recommended daily dosage unless directed by a doctor
do not put into the rectum by using fingers or any mechanical device
or applicator
STOP USE AND ASK A DOCTOR IF
bleeding occurs
condition worsens
symptoms persist for more than 7 days or clear up and occur again
within a few
days. Do not begin use of any other hydrocortisone product unless you
have
consulted a doctor.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
_DIRECTIONS_
adults: when practical, cleanse the affected area by patting or
blotting with an
appropriate cleansing wipe. Gently dry by patting or blotting with a
tissue or soft
cloth before application of this product.
when first opening the tube, puncture foil seal with top end of cap
adults and children 12 years of age and older: apply to the affected
area not more
than 3 to 4 times daily
children under 12 years of age: do not use, consult a doctor
_OTHER INFORMATION_
store at 20-25°C (68-77°F)
_INACTIVE INGREDIENTS_
anhydrous citric acid, butylated hydroxyanisole,
carboxymethylcellulose sodium, cetyl
alcohol, citric acid monohydrate, edetate disodium, glycerin, glyceryl
oleate, glyceryl
stearate, lanolin, methylparaben, propyl gallate, propylene glycol,
propylparaben, purified
water, simethicone emulsion, sodium benzoate, sodium lauryl sulfate,
stearyl alcohol,
white petrolatum, xanthan gum
_QUESTIONS OR COMMENTS?_
Call weekdays 9 AM to 5 PM EST at 1-800-99PREPHor 1-800-997-7374.
PRINCIPAL DISPLAY PANEL
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