RUGBY BENZOYL PEROXIDE ACNE MEDICATION- benzoyl peroxide lotion

Rugby Benzoyl Peroxide by

Drug Labeling and Warnings

Rugby Benzoyl Peroxide by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories, Inc., Garcoa, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Benzoyl peroxide 5%

Purpose

Acne medication

Use

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

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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)

INGREDIENTS AND APPEARANCE

RUGBY BENZOYL PEROXIDE   ACNE MEDICATION
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1057
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Carboxymethylcellulose Sodium, Unspecified Form (UNII: K679OBS311)
Edetate Disodium (UNII: 7FLD91C86K)
Laureth-4 (UNII: 6HQ855798J)
Sodium Hydroxide (UNII: 55X04QC32I)
Titanium Dioxide (UNII: 15FIX9V2JP)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1057-75	1 in 1 CARTON	01/20/2015
1		29.5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	01/20/2015

Labeler - Rugby Laboratories, Inc. (079246066)

Registrant - Garcoa, Inc. (103039178)

Establishment
Name	Address	ID/FEI	Business Operations
Garcoa, Inc.		036464697	MANUFACTURE(0536-1057)