RUGBY BENZOYL PEROXIDE  ACNE MEDICATION- benzoyl peroxide gel 
A-S Medication Solutions

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.

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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

HOW SUPPLIED

Product: 50090-1792

NDC: 50090-1792-0 42.5 mL in a TUBE / 1 in a CARTON

Benzoyl Peroxide

Label Image
RUGBY BENZOYL PEROXIDE   ACNE MEDICATION
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-1792(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 FORM (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:50090-1792-01 in 1 CARTON04/28/2015
142.5 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D01/20/2015
Labeler - A-S Medication Solutions (830016429)
Establishment
NameAddressID/FEIBusiness Operations
A-S Medication Solutions830016429RELABEL(50090-1792)

Revised: 2/2023
Document Id: e9b68eed-e2da-4bba-b920-21b675c323f5
Set id: 98e1bf69-ef71-4e38-8357-54c60d9d03df
Version: 12
Effective Time: 20230204
 
A-S Medication Solutions