RUGBY BENZOYL PEROXIDE  ACNE MEDICATION- benzoyl peroxide gel 
Rugby Laboratories, Inc.

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Rugby® 5% Benzoyl Peroxide Gel
Acne Medication

Drug Facts

Active ingredient

Benzoyl peroxide 5%

Purpose

Acne treatment

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 - 42.5 g Tube Carton

NDC 0536-1055-56

Rugby®

Acne Medication
Benzoyl Peroxide Gel USP, 5%

5

Net Wt 1.5 oz (42.5 g)

Principal Display Panel - 42.5 g Tube Carton
RUGBY BENZOYL PEROXIDE   ACNE MEDICATION
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1055
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Carboxymethylcellulose Sodium, Unspecified (UNII: K679OBS311)  
Edetate Disodium (UNII: 7FLD91C86K)  
Laureth-4 (UNII: 6HQ855798J)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1055-561 in 1 CARTON01/20/2015
142.5 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:0536-1055-251 in 1 CARTON10/31/2019
260 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:0536-1055-571 in 1 CARTON10/31/2019
390 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM00601/20/2015
Labeler - Rugby Laboratories, Inc. (079246066)
Registrant - Garcoa, Inc. (103039178)
Establishment
NameAddressID/FEIBusiness Operations
Garcoa, Inc.036464697MANUFACTURE(0536-1055)

Revised: 2/2024
Document Id: cc9eedb4-62ed-4810-a8a6-458cc7433eb9
Set id: de9ac9fe-b6af-45b7-bbf2-70c47f45885b
Version: 6
Effective Time: 20240209
 
Rugby Laboratories, Inc.