HYDROCORTISONE- 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:

Sion Biotext Medical Ltd

INN (International Name):

HYDROCORTISONE ACETATE

Composition:

HYDROCORTISONE ACETATE 1 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antipruritic (Anti-Itch) 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 Other uses of this product should be under the advice and supervision of a doctor. - in the eyes - for diaper rash - if you have vaginal discharge - more than the recommended daily dosage ​you are pregnant or breast feeding - the condition persists or gets worse or if, - if symptoms persist for more than 7 days or clear up and occur again within a few days

Authorization status:

OTC monograph not final

Summary of Product characteristics

HYDROCORTISONE- HYDROCORTISONE ACETATE CREAM
SION BIOTEXT MEDICAL LTD
_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._
----------
HYDROCORTISONE CREAM 1%
ACTIVE INGREDIENT
Hydrocortisone Acetate, USP (1% w/w)
PURPOSE
Antipruritic (Anti-Itch)
USES:
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
Other uses of this product should be under the advice and supervision
of a doctor.
WARNINGS:
FOR EXTERNAL USE ONLY
DO NOT USE:
in the eyes
for diaper rash
if you have vaginal discharge
more than the recommended daily dosage
ASK A DOCTOR BEFORE USE IF
​YOU ARE PREGNANT OR BREAST FEEDING
STOP USE AND ASK A DOCTOR IF:
THE CONDITION PERSISTS OR GETS WORSE OR IF,
IF SYMPTOMS PERSIST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN
WITHIN A FEW DAYS
KEEP OUT OF REACH OF CHILDREN
IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER
RIGHT
AWAY.
DIRECTIONS:
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
After application, discard pad
Do not flush in toilet
OTHER INFORMATION:
Store at 20
- 25
C (68
- 77
F)
Avoid excessive heat and humidity
INACTIVE INGREDIENTS:
o
o
o
o
Cetostearyl Alcohol, Chlorocresol, CETETH-20, Edetate Disodium, Liquid
Paraffin,
Propylene Glycol, Purified Water, Sodium Betabisulphite, White Soft
Paraffin
Sion Biotext Medical Ltd. Hagoshrim, 1222500, ISRAEL. Email:
[e-mail]
Tel: +9