HYDROCORTISONE- hydrocortisone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

HYDROCORTISONE

Composition:

HYDROCORTISONE 10 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

HYDROCORTISONE- HYDROCORTISONE CREAM
PROFICIENT RX LP
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
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HYDROCORTISONE MAXIMUM STRENGTH
_ACTIVE INGREDIENT_
Hydrocortisone 1.0%
_PURPOSE_
Anti-itch
_USES_
for the temporary relief of itching associated with minor skin
irritations, inflammation and rashes due to:
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Other uses of this product should be only under the advice and
supervision of a doctor.
_WARNINGS_
FOR EXTERNAL USE ONLY
DO NOT USE
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WHEN USING THIS PRODUCT
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cosmetics
soaps
jewelry
insect bites
psoriasis
eczema
detergents
seborrheic dermatitis
external genital and anal itching
poison ivy, poison oak, or poison sumac
for the treatment of diaper rash. Consult a doctor.
for external genital itching if you have vaginal discharge. Consult a
doctor.
avoid contact with eyes
do not use more than directed unless told to do so by a doctor
do not put directly into the rectum by using fingers or any mechanical
device or applicator
STOP USE AND ASK A DOCTOR IF
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KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
immediately.
_DIRECTIONS_
ADULTS AND CHILDREN 2 YEARS OF AGE AND OLDER
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CHILDREN UNDER 2 YEARS OF AGE
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FOR EXTERNAL ANAL ITCHING
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_OTHER INFORMATION_
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You may report serious side effects to: _130 Vintage Drive,
Huntsville, AL 35811._
_INACTIVE INGREDIENTS_
cetyl alcohol, diazolidinyl urea, isopropyl palmitate, mineral
oil/lanolin alcohol, polysorbate 40,
propylene glycol, propylene glycol monostearate, purified water,
sorbic acid, sorbitan monopalmitate,
stearyl alcohol, xanthan gum
PRINCIPAL DISPLAY PANEL
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
a