PROACTIV PLUS PORE TARGETING TREATMENT- benzoyl peroxide gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)

Available from:

THE PROACTIV COMPANY LLC

INN (International Name):

BENZOYL PEROXIDE

Composition:

BENZOYL PEROXIDE 2.5 mg in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Acne treatment gel for the management of acne                 

Authorization status:

OTC monograph final

Summary of Product characteristics

PROACTIV PLUS PORE TARGETING TREATMENT- BENZOYL PEROXIDE GEL
THE PROACTIV COMPANY 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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PROACTIV+ PORE TARGETING TREATMENT
_DRUG FACTS_
ACTIVE INGREDIENT
Benzoyl peroxide 2.5%
PURPOS E
Acne treatment gel
US E
for the management of acne
WARNINGS
FOR EXTERNAL USE ONLY
WHEN USING THIS PRODUCT
do not use this product more than three times per day.
skin irritation and dryness are more likely to occur if you use
another topical acne medication at the
same time. If irritation occurs, only use one topical acne medication
at a time.
avoid unnecessary sun exposure and use a sunscreen.
avoid contact with the eyes, lips, and mouth.
avoid contact with hair and dyed fabrics, which may be bleached by
this product.
skin irritation may occur, characterized by redness, burning, itching,
peeling, or possibly swelling.
Irritation may be reduced by using the product less frequently or in a
lower concentration.
DO NOT USE if you
have very sensitive skin
are sensitive to benzoyl peroxide
STOP USE AND ASK A DOCTOR
if irritation becomes severe.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
_Sensitivity Test for a New User:_ Apply product sparingly to one or
two small affected areas during the
first 3 days. If no discomfort occurs, follow the directions stated
below.
cleanse the skin thoroughly before applying this product.
cover the entire affected area with a thin layer one to three times
daily.
because excessive drying of the skin may occur, start with one
application daily, then gradually
increase to two or three times daily if needed or as directed by a
doctor.
if bothersome dryness or peeling occurs, reduce application to once a
day or every other day.
if going outside, apply sunscreen after using this product. If
irritation or sensitivity develop