RUGBY BENZOYL PEROXIDE WASH ACNE MEDICATION- benzoyl peroxide lotion

Rugby Benzoyl Peroxide Wash by

Drug Labeling and Warnings

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

Drug Details [pdf]

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Drug Facts

Active ingredient

Benzoyl peroxide USP 5%

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

• shake well
• Wet area to be cleansed
• Sensitive Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow directions stated below
• one to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry
• 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, cetyl alcohol, disodium EDTA, disodium laureth sulfosuccinate, glycerin, glyceryl stearate, laureth-7, magnesium aluminum silicate, PEG-100 stearate, propylene glycol, sodium coco-sulfate, sodium lauroamphoacetate, water, xanthan gum

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 - 236 mL Bottle Label

Rugby®
NDC: 0536-1259-19

Benzoyl Peroxide
Wash USP
5%

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

8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

RUGBY BENZOYL PEROXIDE WASH   ACNE MEDICATION
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1259
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
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
Cetyl Alcohol (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
Disodium Laureth Sulfosuccinate (UNII: D6DH1DTN7E)
Glycerin (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
Laureth-7 (UNII: Z95S6G8201)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
PEG-100 Stearate (UNII: YD01N1999R)
Propylene Glycol (UNII: 6DC9Q167V3)
Sodium Coco-Sulfate (UNII: 3599J29ANH)
Sodium Lauroamphoacetate (UNII: SLK428451L)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1259-19	236 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	12/17/2019
2	NDC: 0536-1259-63	148 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	12/17/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	12/17/2019

Labeler - Rugby Laboratories (079246066)

Registrant - Garcoa, Inc. (036464697)

Establishment
Name	Address	ID/FEI	Business Operations
Sigan Industries, Inc.		255106239	MANUFACTURE(0536-1259)