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Acne Medication 10 by Rugby Laboratories

Dosage form: gel
Ingredients: BENZOYL PEROXIDE 100mg in 1g
Labeler: Rugby Laboratories
NDC Code: 0536-4092

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 10%


Acne treatment

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


For external use only

Do not use
  • if you have sensitive skin or are sensitive to benzoly peroxide

When using this product
  • apply to affected ares only
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips and mouth
  • this product may bleach hair or dyed fabrics
  • with other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. Only one medication should be used unlee directed by a physician
  • skin irritaion may occur characterized by redness, burning, itching, peeling or possible swelling

Stop and ask a doctor if
  • irritation becomes severe

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

  • clean the skin thoroughly before applying
  • cover the entire affected area with a thin layer 1 to 3 times daily
  • because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application ot once a day or every other day.
  • if going outside, use a sunscreen. Allow benzoyl peroxide to dry, then follow directions in the sunscreen labeling.
  • Sensitivity Test for 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.

Other information
  • store at room temperature 15 degrees to 30 degrees C (59 degrees to 86 degrees F)
  • Lot number & expiration date: See box or crimp of the tube

Inactive ingredients

Brij 30, carbomer, diisopropanolamine, edetate sodium, Purified water

Principal display panel

10% Benzoyl Peroxide Gel

benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-4092
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Inactive Ingredients
Ingredient NameStrength
#Item CodePackage Description
1NDC:0536-4092-561 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.