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., Sigan Industries, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Benzoyl peroxide 10% USP

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
• 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 frequent or in a lower concentration.

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 (1-800-222-1222) right away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.

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 at room temperature.

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
17177 N Laurel Park Dr., Suite 233
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 29.5 mL Tube Carton

NDC: 0536-1058-75

Rugby®

Acne Medication
Benzoyl Peroxide Lotion USP, 10%

10

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: 0536-1058
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	100 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: 0536-1058-75	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. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries, Inc.		255106239	MANUFACTURE(0536-1058)