Label: CLEARASIL DAILY CLEAR VANISHING ACNE TREATMENT- benzoyl peroxide cream
- NDC Code(s): 63824-303-02
- Packager: Reckitt Benckiser LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated November 8, 2012
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient
Benzoyl peroxide 10%Close
for the treatment of acneClose
For external use only
When using this product
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with the eyes, lips and mouth
- avoid contact with hair and dyed fabrics, which may be bleached by 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.
- 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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- clean the skin thoroughly before applying this product
- cover the entire affected area with a thin layer one to three times daily
- because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
- Other information
- keep tightly closed
- store at 20-25 °C (68-77 °F)
- Inactive ingredients
Water, Propylene Glycol, Aluminium Hydroxide, Bentonite, Glyceryl Stearate SE, PEG-12, Isopropyl Myristate, Methylparaben, Carbomer, Potassium Hydroxide, PropylparabenClose
Call 1-866-25-CLEAR (1-866-252-5327). You may also report side effects to this phone number.Close
- SPL UNCLASSIFIED SECTION
Distributed by: Reckitt Benckiser LLCClose
Parsippany, NJ 07054-0224
Made in USA © RB 2011
- PRINCIPAL DISPLAY PANEL - 28 g Tube Carton
Benzoyl Peroxide 10% Acne Medication
- INGREDIENTS AND APPEARANCE
CLEARASIL DAILY CLEAR VANISHING ACNE TREATMENT
benzoyl peroxide cream
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63824-303 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 10 g in 100 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Propylene Glycol (UNII: 6DC9Q167V3) Aluminum Hydroxide (UNII: 5QB0T2IUN0) Bentonite (UNII: A3N5ZCN45C) Glyceryl Stearate SE (UNII: FCZ5MH785I) Polyethylene Glycol 600 (UNII: NL4J9F21N9) Isopropyl Myristate (UNII: 0RE8K4LNJS) Methylparaben (UNII: A2I8C7HI9T) Potassium Hydroxide (UNII: WZH3C48M4T) Propylparaben (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63824-303-02 1 in 1 CARTON 1 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part333D 09/01/2011 Labeler - Reckitt Benckiser LLC (094405024)