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


Benzoyl Peroxide Wash 7% (benzoyl peroxide 7%)

BENZOYL PEROXIDE WASH  - 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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Benzoyl Peroxide Wash 7% (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 use.
  • Wet areas to be treated and liberally apply product by massaging gently into skin for 10-20 seconds, working into a full lather.
  • Rinse thoroughly and pat dry.
  • Avoid contact with eyes, eyelids, and lips.
  • 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

BENZOYL PEROXIDE WASH 
benzoyl peroxide emulsion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68032-600
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 mL
Inactive Ingredients
Ingredient Name Strength
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  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68032-600-16 473 mL 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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