Clinical Information
Gen. Code and Des.
5819 benzoyl peroxide TOPICAL LOTION 5 %
Strength
5 %
Dose Form
LOTION (ML)
Product Category
OT Over the Counter
Fine Line Class
370037103718 Prvt Lbl Facial & Body Acne Medications
DEA Class
NC
OMP Family
AHFS Class
84280000 KERATOLYTIC AGENTS
Active Ingredients
1955 benzoyl peroxide 94360
Inactive Ingredients
3785 edetic acid 60004
RUGBY BENZOYL PEROXIDE ACNE MEDICATION- benzoyl peroxide lotion
Rugby 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.
----------
Rugby 5% Benzoyl Peroxide Lotion
Drug Facts
Active ingredient
Benzoyl peroxide 5%
Purpos e
Acne medication
Us e
for the treatment of acne
Warnings
For external use only
Do not use this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.
When using this product
n keep away from eyes, lips and mouth
avoid unnecessary sun exposure and use a sunscreen
avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this
product
skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling.
Mild irritation may be reduced by using the product less frequently or in a lower concentration. If
irritation becomes severe, discontinue use; if irritation still continues, consult a doctor.
using other topical acne medication at the same time or immediately following the use of this
product may increase dryness or irritation of the skin. If this occurs, only one medication should be
used unless directed by a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right
away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.
Directions
Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1-3
times daily. If bothersome dryness or peeling occurs, reduce application to once a day.
Other information
Keep tightly closed. Avoid storing at extreme temperatures (below 40° F and above 100° F).
®
Inactive ingredients
carbomer, disodium EDTA, laureth-4, sodium hydroxide, titanium dioxide, water
Questions or comments?
1-800-645-2158
Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150
PRINCIPAL DISPLAY PANEL - 29.5 mL Tube Carton
NDC 0536-1057-75
Rugby
Acne Medication
Benzoyl Peroxide Lotion USP, 5%
5
1 fl oz (29.5 mL)
®
RUGBY BENZOYL PEROXIDE ACNE MEDICATION
benzoyl peroxide lotion
Product Information
Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:0 536 -10 57
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzo yl Pero xide (UNII: W9WZN9A0GM) (Benzo yl Pero xide - UNII:W9WZN9A0GM) Benzo yl Pero xide 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Ca rbo xymethylcellulo se So dium, Unspecified Fo rm (UNII: K6 79OBS311)
Edeta te Diso dium (UNII: 7FLD9 1C8 6K)
La ureth-4 (UNII: 6HQ8 5579 8 J)
So dium Hydro xide (UNII: 55X0 4QC32I)
Tita nium Dio xide (UNII: 15FIX9V2JP)
Wa ter (UNII: 0 59QF0KO0R)
Product Characteristics
Color WHITE Score
Shape Siz e
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0 536 -10 57-75 1 in 1 CARTON 0 1/20 /20 15
1 29 .5 mL in 1 TUBE; Type 0 : No t a Combinatio n Pro duct
Marketing Information
Rugby Laboratories, Inc.
Marke ting Category Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date
OTC MONOGRAPH FINAL part333D 0 1/20 /20 15
Labeler - Rugby Laboratories, Inc. (079246066)
Registrant - Garcoa, Inc. (103039178)
Establishment
Name Addre ss ID/FEI Busine ss Ope rations
Garco a, Inc. 0 36 46 46 9 7 MANUFACTURE(0 536 -10 57)
Revised: 9/2019
