HYDROCORTISONE 1%- hydrocortisone ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Trifecta Pharmaceuticals Usa Llc

INN (International Name):

HYDROCORTISONE

Composition:

HYDROCORTISONE 1 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Anti-Itch temporary relieves itching associated with minor skin irritations, inflammation and rashes due to: ● eczema        ● seborrheic dermatitis    ● psoriasis   ● insect bites   ● poison ivy, oak, sumac   ● soaps ● detergents    ● cosmetics                     ● jewelry     ● external genital and anal itching 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 1%- HYDROCORTISONE OINTMENT
TRIFECTA PHARMACEUTICALS USA LLC
_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 OINTMENT 1% ANTIPRURITIC (ANTI-ITCH)
_DRUG FACTS_
_ACTIVE INGREDIENT_
Hydrocortisone 1%
_PURPOSE_
Anti-Itch
KEEP OUT OF THE REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
immediately.
_USES_
temporary relieves itching associated with minor skin irritations,
inflammation and rashes
due to:
● eczema ● seborrheic dermatitis ● psoriasis ● insect bites
● poison ivy, oak,
sumac ● soaps
● detergents ● cosmetics ● jewelry ● external genital and anal
itching
Other uses of this product should be only under the advice and
supervision of a doctor
_WARNINGS_
● FOR EXTERNAL USE ONLY ● AVOID CONTACT WITH THE EYES
● DO NOT PUT THIS PRODUCT INTO THE RECTUM BY USING FINGERS OR ANY
MECHANICAL
DEVICE OR APPLICATOR
● STOP USING THIS PRODUCT AND ASK A DOCTOR ● in case of bleeding
● if condition worsens, or if symptoms persist for more than 7 days
or clear up and
occur again within a few days
● before you begin using any other hydrocortisone product
DO NOT USE THIS PRODUCT AND ASK A DOCTOR
● if you have a vaginal discharge ● before treating diaper rash
● before using on
children under 2 years of age
FOR EXTERNAL ANAL ITCHING USERS: ● do not exceed the recommended
daily dosage
unless directed by a doctor
● in case of bleeding, consult a doctor promptly
● do not put this product into the rectum by using fingers or any
mechanical device or
applicator
● children under 12 years of age: consult a doctor
Before using any medication, read all label directions. Keep this
carton. It contains
important information.
_DIRECTIONS_
● when practical, cleanse the affected area with mild soap and warm
water and rinse
thoroughly.
● gently dry by patting or blo