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Acne Medication 5 by Rugby Laboratories

Dosage form: gel
Ingredients: BENZOYL PEROXIDE 50mg in 1g
Labeler: Rugby Laboratories
NDC Code: 0536-4089

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.

Drug Facts

Active Ingredient

Benzoyl peroxide 5%


Acne Treatment

Keep out of reach of children

If swallowed get medical help or contact a Poison Control Center right away.

  • Clean the skin thoroughly before applying this product
  • Cover entire affected area with a thin layer one to three times daily
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day
  • If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor
  • Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above.


For external use only


Use twice daily or as directed by Physician.

Inactive Ingredients

Brij 30, carbomer, diisopropanolamine, disodium edetate, purified water

Do not use if you
  • have very sensitive skin
  • are sensitive to benzoyl peroxide

  • treats acne
  • dries up acne pimples
  • helps prevent new acne pimples  

When using this product
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleached by this product
  • skin irritation may occur characterized by redness, burning, itching, peeling or possible swetting. Irritation may be reduced by using the product less frequently or in a lower concentration
  • skin irritation and dryness are 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 ask a doctor

If irritation becomes severe 

Other information

Store at room temperature 15 degrees to 30 degrees C (59 degrees to 86 degrees F)
For lot number and expiration date: See box or crimp of tube

Questions or comments?

 Call 1-800-645-2158

Principal display panel


benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-4089
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
Product Characteristics
ColorWHITE (Off-White) Score    
FlavorImprint Code
#Item CodePackage Description
1NDC:0536-4089-561 TUBE (1 CARTON) in 1 CARTON
142.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D10/29/2012
Labeler - Rugby Laboratories (191427277)

Revised: 01/2013
Rugby Laboratories

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.