RUGBY ACNE MEDICATION BENZOYL PEROXIDE- benzoyl peroxide gel 
Rugby Laboratories

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Rugby® Acne Medication Benzoyl Peroxide Gel USP 2.5%

Drug Facts

Active ingredient

Benzoyl Peroxide USP 2.5%

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, chlorphenesin, disodium EDTA, ethylhexylglycerin, hydroxyl methylcellulose, laureth-4, phenoxyethanol, 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 0536-1129-25

Acne Medication
Benzoyl Peroxide Gel USP

2.5%

Greaseless, Vanishing Formula

NET WT 2.1 OZ (60 g)

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
RUGBY ACNE MEDICATION BENZOYL PEROXIDE 
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1129
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide25 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
Chlorphenesin (UNII: I670DAL4SZ)  
Edetate Disodium (UNII: 7FLD91C86K)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Hypromellose, Unspecified (UNII: 3NXW29V3WO)  
Laureth-4 (UNII: 6HQ855798J)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Water (UNII: 059QF0KO0R)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1129-251 in 1 CARTON10/31/2019
160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM00610/31/2019
Labeler - Rugby Laboratories (079246066)
Registrant - Garcoa, Inc. (036464697)
Establishment
NameAddressID/FEIBusiness Operations
Sigan Industries INC255106239MANUFACTURE(0536-1129)

Revised: 3/2024
Document Id: a22c240e-154c-45a2-b2b4-fcea6e0584d5
Set id: 2b2a7e51-263f-4d1c-8f01-c9914b538313
Version: 3
Effective Time: 20240301
 
Rugby Laboratories