Benzoyl Peroxide Cleansing

Dosage form: lotion
Ingredients: BENZOYL PEROXIDE 40mg in 1g
Labeler: River’s Edge Pharmaceuticals, LLC
NDC Code: 68032-593

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.

4% Benzoyl Peroxide Cleansing Lotion (benzoyl peroxide 4%)

Active Ingredients

Benzoyl peroxide 4%

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.
  • Wash the affected areas once a day during the first week, and twice a day thereafter as tolerated.
  • Wet skin areas to be treated; apply product, working into a full lather.
  • Rinse thoroughly and pat dry.
  • Frequency of use should be adjusted to obtain the desired clinical response. Clinically visible improvement will normally occur by the third week of therapy. Maximum lesion reduction may be expected after approximately eight to twelve weeks of drug use. Continuing use of the drug is normally required to maintain a satisfactory clinical response.
  • 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 Ingredientscetyl alcohol, citric acid, dimethyl isosorbide, docusate sodium, hydroxypropyl methylcellulose, laureth -12, magnesium aluminum silicate, propylene glycol, purified water, sodium chloride, sodium hydroxide, sodium lauryl sulfate, and sodium lauryl sulfoacetate.

Questions? Comments?

Call 1-866-934-6025

BENZOYL PEROXIDE CLEANSING 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68032-593
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETYL ALCOHOL 
CITRIC ACID MONOHYDRATE 
DIMETHYL ISOSORBIDE 
DOCUSATE SODIUM 
HYPROMELLOSE 2208 (100 MPA.S) 
LAURETH-12 
MAGNESIUM ALUMINUM SILICATE 
PROPYLENE GLYCOL 
WATER 
SODIUM CHLORIDE 
SODIUM HYDROXIDE 
SODIUM LAURYL SULFATE 
SODIUM LAURYL SULFOACETATE 
Packaging
#Item CodePackage Description
1NDC:68032-593-11297 g 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

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.

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