BP CLEANSER - benzoyl peroxide emulsion 
River’s Edge Pharmaceuticals, LLC

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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Active Ingredients

Benzoyl peroxide 4.25%

Purpose

Acne treatment

Uses

For the treatment of acne.

Warnings

For External Use Only.
When using this product

  • 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.

Do not use if you

  • Have very sensitive skin.
  • Are sensitive to benzoyl peroxide.

When using this product

  • Avoid unnecessary sun exposure and use a sunscreen.
  • Avoid contact with the eyes, lips, 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 possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Stop and ask a doctor if

  • Irritation becomes severe.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

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

Directions

  • Apply to affected areas once or twice daily or as directed by your physician.
  • Wet skin and liberally apply to areas to be cleansed.
  • Massage gently into skin for 10-20 seconds, working into a full lather.
  • Rinse thoroughly and pat dry.
  • If excessive drying occurs, it may be controlled by rinsing off product sooner or using less often.
  • 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.

Other Information

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F).

Inactive Ingredients

allantoin, aloe barbadensis leaf extract, benzyl alcohol, camellia oleifera leaf (green tea) extract, carbomer, cetyl alcohol, disodium laureth sulfosuccinate, glycerin, glyceryl stearate, magnesium aluminum silicate, octoxynol-13, panthenol, PEG-100 stearate, PPG-14 palmeth-60 hexyl dicarbamate, propylene glycol, purified water, sodium citrate, sodium hyaluronate, triethanolamine, and xanthan gum.

Questions? Comments?

Call 1-866-934-6025

label
BP CLEANSER 
benzoyl peroxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68032-602
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE42.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALLANTOIN 
ALOE VERA LEAF 
BENZYL ALCOHOL 
GREEN TEA LEAF 
CARBOMER 1342 
CETYL ALCOHOL 
DISODIUM LAURETH SULFOSUCCINATE 
GLYCERIN 
GLYCERYL MONOSTEARATE 
MAGNESIUM ALUMINUM SILICATE 
OCTOXYNOL 9 
PANTHENOL 
POLYOXYL 100 STEARATE 
PROPYLENE GLYCOL 
WATER 
SODIUM CITRATE 
HYALURONATE SODIUM 
TROLAMINE 
XANTHAN GUM 
Packaging
#Item CodePackage Description
1NDC:68032-602-16473 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333D03/23/201103/31/2013
Labeler - River’s Edge Pharmaceuticals, LLC (133879135)

Revised: 11/2011
 
River’s Edge Pharmaceuticals, LLC