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

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Rugby® 10% Benzoyl Peroxide Gel

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 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

Other information

Inactive ingredients

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

Questions or comments?

1-800-645-2158

Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

Rugby®
NDC 0536-1056-25

Compare to
active ingredient
in Clean & Clear®
Persa-Gel®*

Acne Medication
Benzoyl Peroxide Gel USP
10%

Greaseless, Vanishing Formula

NET WT 2.1 OZ (60 g)

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
RUGBY BENZOYL PEROXIDE   ACNE MEDICATION
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1056
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide100 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:0536-1056-561 in 1 CARTON01/20/2015
142.5 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:0536-1056-251 in 1 CARTON10/15/2019
260 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(0536-1056)

Revised: 2/2024
Document Id: 9f9ac733-15ab-4374-9f1d-665c7a07a102
Set id: 5cf3da87-ed50-4791-8f71-1b572f3b8f43
Version: 7
Effective Time: 20240209
 
Rugby Laboratories, Inc.