MICRONIZED BENZOYL PEROXIDE 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:

Pharmco Laboratories Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Acne Treatment

Authorization status:

OTC monograph final

Summary of Product characteristics

MICRONIZED BENZOYL PEROXIDE TREATMENT- BENZOYL PEROXIDE GEL
PHARMCO LABORATORIES INC.
_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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MICRONIZED BENZOYL PEROXIDE TREATMENT 5%
_DRUG FACTS_
ACTIVE INGREDIENT
Benzoyl Peroxide 5%
PURPOS E
Acne Treatment
WARNINGS
For external use only
DO NOT USE IF YOU
Have very sensitive skin
Are sensitive to benzoyl peroxide
WHEN USING THIS PRODUCT
Skin irritation and dryness is 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.
If going outside, apply sunscreen after using this product.
If sensitivity develops or irritation becomes severe, stop use and ask
a doctor.
Keep out of reach of children
If swallowed get medical help or call a poison control center
immediately
Keep away from excessive heat or heat sources
DIRECTIONS
Clean 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.
Other sun protection measures include limiting sun exposure and
wearing protective clothing.
OTHER INGREDIENTS
OTHER INGREDIENTS
Carbomer, Edetate Disodium, Glycerine, Propylene Glycol, Saccharide
Isomerate, Sodium Hydroxide,
Water.
OTHER INFORMA