RUGBY BENZOYL PEROXIDE ACNE MEDICATION- 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:

A-S Medication Solutions

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Acne medication for the treatment of acne

Product summary:

Product: 50090-1792 NDC: 50090-1792-0 42.5 mL in a TUBE / 1 in a CARTON

Authorization status:

OTC monograph final

Summary of Product characteristics

RUGBY BENZOYL PEROXIDE ACNE MEDICATION- BENZOYL PEROXIDE GEL
A-S MEDICATION SOLUTIONS
_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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RUGBY 10% BENZOYL PEROXIDE GEL
DRUG FACTS
ACTIVE INGREDIENT
Benzoyl peroxide USP 10%
PURPOSE
Acne medication
USE
for the treatment of acne
WARNINGS
For external use only.
DO NOT USE IF YOU
have very sensitive
are sensitive to benzoyl peroxide
WHEN USING THIS PRODUCT
avoid unnecessary sun exposure and use a sunscreen
avoid contact with eyes, lips and mouth
avoid contact with hair or 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.
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.
STOP USE AND CONSULT A DOCTOR IF
irritation becomes severe
IF PREGNANT OR BREAST-FEEDING, ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison
®
Control Center (1-800-222-1222) immediately.
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
if going outside, apply sunscreen after using this product
if irritation or sensitivity develops, stop use of both products and
ask a doctor.
OTHER INFORMATION
keep tightly closed
store at room temperature
INACTIVE INGREDIENTS
carbomer, disodium EDTA, hydroxypropyl