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Rugby Benzoyl Peroxide Acne Medication

Medically reviewed on April 14, 2017

Dosage form: gel
Ingredients: Benzoyl Peroxide 50mg in 1mL
Labeler: Rugby Laboratories, Inc.
NDC Code: 0536-1055

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Rugby® 5% Benzoyl Peroxide Gel
Acne Medication

Drug Facts

Active ingredient

Benzoyl peroxide 5%


Acne treatment


for the treatment of acne


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.


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?


Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150


NDC 0536-1055-56


Acne Medication
Benzoyl Peroxide Gel USP, 5%


Net Wt 1.5 oz (42.5 g)

benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1055
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Carboxymethylcellulose Sodium, Unspecified Form 
Edetate Disodium 
Sodium Hydroxide 
Titanium Dioxide 
Product Characteristics
FlavorImprint Code
#Item CodePackage Description
1NDC:0536-1055-561 TUBE in 1 CARTON
142.5 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D01/20/2015
Labeler - Rugby Laboratories, Inc. (079246066)
Registrant - Garcoa, Inc. (103039178)
Garcoa, Inc.036464697MANUFACTURE(0536-1055)

Rugby Laboratories, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.