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, Medical Group Care LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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 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 frequently or in a lower concentration.

Stop use and consult a doctor if

irritation becomes severe

If pregnant or breastfeeding

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, glycerin, sodium hydroxide, titanium dioxide, water.

Questions or comments?

1-866-306-9136

You may also report serious side effects to this phone
number
Mon-Fri, 9:00 AM - 5:00 PM Eastern Time.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RUGBY BENZOYL PEROXIDE  ACNE MEDICATION
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1459
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 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO)
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: 0536-1459-25	1 in 1 CARTON	10/31/2025
1		60 g 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 Drug	M006	10/31/2025

Labeler - Rugby Laboratories (079246066)

Registrant - Medical Group Care LLC (085137089)