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Name:Bp Wash
Manufacturer:River’s Edge Pharmaceuticals, Llc
Category:Over-the-counter (OTC) Marketed Drugs


BP 7% Wash (benzoyl peroxide 7%)

BP WASH  - benzoyl peroxide lotion 
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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BP 7% Wash (benzoyl peroxide 7%)

Active Ingredients

Benzoyl peroxide 7%

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

  • Shake well before using.
  • Wet skin areas to be treated; apply BP 7% Wash by massaging gently into skin for 10-20 seconds, working into a full lather.
  • Rinse thoroughly and pat dry.
  • 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

cetearyl alcohol and PEG-3 distearoylamidoethylmonium methosulfate and polysorbate 60, citric acid, cocamidopropyl betaine, cocamine oxide, disodium EDTA, disodium laureth sulfosuccinate, glycerin, hydrogenated castor oil, hypromellose, lemon fragrance, magnesium aluminum silicate, methylparaben, PEG-40 hydrogenated castor oil, PEG-150 pentaerythrityl tetrastearate and PEG-6 caprylic/capric glycerides, poloxamer 182, purified water, and xanthan gum.

Questions? Comments?

Call 1-866-934-6025

label

BP WASH 
benzoyl peroxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68032-591
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE 70 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CETOSTEARYL ALCOHOL  
PEG-3 ALPHA-LINOLENAMIDE  
POLYSORBATE 60  
CITRIC ACID MONOHYDRATE  
COCAMIDOPROPYL BETAINE  
DIHYDROXYETHYL COCAMINE OXIDE  
EDETATE DISODIUM  
DISODIUM LAURETH SULFOSUCCINATE  
GLYCERIN  
HYDROGENATED CASTOR OIL  
HYPROMELLOSE 2208 (100 MPA.S)  
MAGNESIUM ALUMINUM SILICATE  
METHYLPARABEN  
PEG-150 DISTEARATE  
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES  
POLOXAMER 182  
WATER  
XANTHAN GUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68032-591-18 180 g in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333D 03/23/2011

Labeler - River’s Edge Pharmaceuticals, LLC (133879135)

Revised: 03/2011 River’s Edge Pharmaceuticals, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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