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Rugby Benzoyl Peroxide Acne Medication

Medically reviewed on Feb 20, 2018

Dosage form: lotion
Ingredients: Benzoyl Peroxide 100mg in 1mL
Labeler: Rugby Laboratories, Inc.
NDC Code: 0536-1058

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® 10% Benzoyl Peroxide Lotion

Drug Facts

Active ingredient

Benzoyl peroxide 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 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.

Directions

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?

1-800-645-2158

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

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)

RUGBY BENZOYL PEROXIDE   ACNE MEDICATION
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1058
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide100 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Carboxymethylcellulose Sodium 
Edetate Disodium 
Laureth-4 
Sodium Hydroxide 
Titanium Dioxide 
Water 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:0536-1058-751 TUBE in 1 CARTON
129.5 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)
Establishment
NameAddressID/FEIOperations
Garcoa, Inc.103039178MANUFACTURE(0536-1058)

 
Rugby Laboratories, Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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