ATOPALM MAXIMUM STRENGTH ANTI-ITCH- hydrocortisone ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

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Active ingredient:

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

Available from:

NeoPharm Co., Ltd.

INN (International Name):

HYDROCORTISONE

Composition:

HYDROCORTISONE 1 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to: - eczema - insect bites - poison ivy, poison oak, or poison sumac - soaps - detergents - jewelry - seborrheic dermatitis - psoriasis - external genital and anal itching. Other uses of this product should be only under the advice and supervision of a doctor. - for the treatment of diaper rash, consult a doctor  - for external genital itching, if you have a vaginal discharge, consult a doctor - condition worsens - symptoms persist for more than 7 days or clear up and occur again within a few days. Anti-Itch

Authorization status:

OTC monograph final

Summary of Product characteristics

                                ATOPALM MAXIMUM STRENGTH ANTI-ITCH - HYDROCORTISONE OINTMENT
NEOPHARM CO., 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._
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ATOPALM MAXIMUM STRENGTH ANTI-ITCH OINTMENT
ACTIVE INGREDIENT
Active Ingredient...........................Purpose
Hydrocortisone 1%.......................Anti-Itch
US ES
for the temporary relief of itching associated with minor skin
irritations, inflammation and rashes due to:
- eczema - insect bites - poison ivy, poison oak, or poison sumac -
soaps - detergents - jewelry -
seborrheic dermatitis - psoriasis - 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.
DO NOT USE
- for the treatment of diaper rash, consult a doctor - for external
genital itching, if you have a vaginal
discharge, consult a doctor
WHEN USING THIS PRODUCT
- avoid contact with the eyes - do not begin the use of any other
hydrocortisone product unless you
have consulted a doctor - for external anal itching 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 in rectum
by using fingers or any mechanical devise for application.
STOP USE AND ASK A DOCTOR IF
- condition worsens - symptoms persist for more than 7 days or clear
up and occur again within a few
days.
KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
OTHER SAFETY INFORMATION
If swallowed, get medical help or call a Poison Control Center
immediately.
DIRECTIONS
Adults and children 2 years of age and older - apply to affected area
not more than 3 to 4 times daily
Children under 2 years of age - Do not use. Consult a doctor. For
external anal itching - adults, when
practical, cleanse the affected area with mild soap, and warm water,
and rinse thoroughly, or by patting
or blotting with toilet 
                                
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