HYDROCORTISONE- hydrocortisone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dynarex Corporation

INN (International Name):

HYDROCORTISONE

Composition:

HYDROCORTISONE 1 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- minor skin irritations, inflammation and rashes due to - eczema - insect bites - poison ivy - poison oak - poison sumac - soaps - detergents - cosmetics - jewelry - seborrheic dermatitis - psoriasis - scrapes -  genital - feminine and - anal itching - other uses of this product should be only under the advice and supervision of a doctor - 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 - the condition persists or gets worse - symptoms clear up and occur again within a few days - you are pregnant or breast feeding For temporary relief of minor skin irritations and external itching.

Authorization status:

OTC monograph final

Summary of Product characteristics

HYDROCORTISONE - HYDROCORTISONE CREAM
DYNAREX CORPORATION
_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 USP 10 mg Antipruritic (anti-itch)
US ES :
For temporary relief of;
minor skin irritations, inflammation and rashes due to
eczema
insect bites
poison ivy
poison oak
poison sumac
soaps
detergents
cosmetics
jewelry
seborrheic dermatitis
psoriasis
scrapes
and for external itching of;
genital
feminine and
anal itching
other uses of this product should be only under the advice and
supervision of a doctor
WARNINGS :
FOR EXTERNAL USE ONLY
DO NOT USE:
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
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.
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
OTHER INFORMATION:
Store at a controlled room temperature 15 deg - 30 deg C (59 deg - 86
deg F)
Avoid excessive heat and humidity
tamper evident, do not use if packet is torn, cut or open
INACTIVE INGREDIENTS:
citric acid, glycerin, glycerol stearate, methylparaben, petrolatum,
polysorbate 80, propyl paraben,