ACNE MEDICATION 10- benzoyl peroxide gel 
Rugby Laboratories

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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Drug Facts

Active ingredient

Benzoyl Peroxide 10%

Purpose

Acne treatment

Uses

Warnings

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.

Directions

Other information

Inactive ingredients

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

Principal display panel

10% Benzoyl Peroxide Gel

Acne Medication Gel 10

ACNE MEDICATION 10 
benzoyl peroxide gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0536-4092
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 100 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
STEARETH-30 (UNII: 5776GCL1DG)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
DIISOPROPANOLAMINE (UNII: 0W44HYL8T5)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-4092-56 1 in 1 CARTON
1 42.5 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 10/29/2012
Labeler - Rugby Laboratories (191427277)

Revised: 1/2013
Document Id: 03b94e6c-f864-48ad-94c1-f08ddc2c2de0
Set id: 18e83482-f792-49c4-9faa-f26521832cf2
Version: 3
Effective Time: 20130115
 
Rugby Laboratories