HYDROCORTISONE ACETATE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)

Available from:

Kinray Inc.

INN (International Name):

HYDROCORTISONE ACETATE

Composition:

HYDROCORTISONE ACETATE 1 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Hydrocortisone is for temporary relief of; minor skin irritations Itching and rashes due to; eczema insect bites poison ivy poison oak poison sumac soaps detergents cosmetics jewelry and for external itching of; genital feminine and anal itching - in the eyes - longer than 1 week unless directed by a physician - for diaper rash - if you have vaginal discharge - more than the recommended daily dosage unless directed by a doctor - in the rectum bu using fingers or any other mechanical device or applicator - For temporary relief of minor skin irritations and external itching. - the condition persists or gets worse - symptoms clear up and occur again within a few days - you are pregnant or breast feeding

Authorization status:

OTC monograph not final

Summary of Product characteristics

HYDROCORTISONE ACETATE- HYDROCORTISONE ACETATE CREAM
KINRAY INC.
_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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HYDROCORTIS ONE
Active Ingredient Purpose
Hydrocortisone Acetate 1% Antipruritic (anti-itch)
WARNINGS :
FOR EXTERNAL USE ONLY
PURPOS E
Hydrocortisone is for temporary relief of;
minor skin irritations
Itching and rashes due to;
eczema
insect bites
poison ivy
poison oak
poison sumac
soaps
detergents
cosmetics
jewelry
and for external itching of;
genital
feminine and
anal itching
INDICATIONS AND USAGE
in the eyes
longer than 1 week unless directed by a physician
for diaper rash
if you have vaginal discharge
more than the recommended daily dosage unless directed by a doctor
in the rectum bu using fingers or any other mechanical device or
applicator
For temporary relief of minor skin irritations and external itching.
STOP USE AND ASK A PHYSICIAN IF:
the condition persists or gets worse
symptoms clear up and occur again within a few days
you are pregnant or breast feeding
KEEP OUT OF REACH OF CHILDREN
If swallowed, get medical help or contact a Poison Control Center
right away.
DOSAGE AND ADMINISTRATION
ADULTS AND CHILDREN OVER 2 YEARS OF AGE
Apply evenly to affected area no more than 3 or 4 times daily.
CHILDREN UNDER 2 YEARS OF AGE
Do not use
consult a physician
ADULTS
When practical, cleanse the affected area with mild soap and warm
water and rinse thoroughly
Gently dry, patting and blotting with bathroom tissue or soft cloth
before applying
apply externally to the area up to 6 times daily or after each bowel
movement
OTHER INFORMATION:
Store at 20 deg - 25 deg C (68 deg - 77 deg F)
Avoid excessive heat and humidity
INACTIVE INGREDIENTS
Inactive Ingredients: Cetomacrogol 1000, Cetostearyl alcohol,
Chlorocresol, Edetate sodium, Liquid
paraffin, Propylene glycol, Purified water, Sodium metabisulphate,
White soft paraffin.
PRINCIPAL DISPLA