Label: LEADER MAXIMUM STRENGTH INVISIBLE ACNE- benzoyl peroxide 10% cream
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Contains inactivated NDC Code(s)
NDC Code(s): 37205-279-10, 37205-279-11 - Packager: Cardinal Health
- 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.
Drug Label Information
Updated September 6, 2012
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Uses
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Warnings
For external use only
Do not use
- on broken skin
- on large areas of the body
- if you have sensitive skin or are sensitive to benzoly peroxide
When using this product
- apply to affected ares only
- avoid unnecessary sun exposure and use a sunscreen
- do not use in or near eyes
- this product may bleach hair or dyed fabrics
- with other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. Only one medication should be used unlee directed by a physician
- skin irritaion may occur characterized by redness, burning, itching, peeling or possible swelling
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Directions
- cleanse the skin thoroughly before applying
- cover the entire affected area with a thin layer 1 to 3 times daily
- because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 to 3 times daily if needed or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application ot once a day or every other day.
- if going outside, use a sunscreen. Allow benzoyl peroxide to dry, then follow directions in the sunscreen labeling.
- Other information
- Inactive ingredients
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
LEADER MAXIMUM STRENGTH INVISIBLE ACNE
benzoyl peroxide 10% creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-279 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 100 mg in 1 g Inactive Ingredients Ingredient Name Strength ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) METHYLPARABEN (UNII: A2I8C7HI9T) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37205-279-10 1 in 1 CARTON 1 NDC:37205-279-11 28 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 06/01/2008 Labeler - Cardinal Health (097537435) Registrant - Lee Pharmaceuticals (056425432) Establishment Name Address ID/FEI Business Operations Cardinal Health 097537435 label(37205-279) Establishment Name Address ID/FEI Business Operations Lee Pharmaceuticals 056425432 pack(37205-279) Establishment Name Address ID/FEI Business Operations Unipack 009248480 manufacture(37205-279)
