RUGBY BENZOYL PEROXIDE ACNE MEDICATION- benzoyl peroxide gel

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 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 methylcellulose, laureth-4, sodium hydroxide, water

Questions or comments?

1-800-645-2158

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Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

Rugby®
NDC: 0536-1056-25

Compare to
active ingredient
in Clean & Clear®
Persa-Gel®*

Acne Medication
Benzoyl Peroxide Gel USP
10%

• Helps to keep skin clear
• Helps dry oily skin
• Helps clear acne pimples

Greaseless, Vanishing Formula

NET WT 2.1 OZ (60 g)

INGREDIENTS AND APPEARANCE

RUGBY BENZOYL PEROXIDE   ACNE MEDICATION
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1056
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: 0536-1056-56	1 in 1 CARTON	01/20/2015
1		42.5 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0536-1056-25	1 in 1 CARTON	10/15/2019
2		60 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(0536-1056)