LEADER MAXIMUM STRENGTH INVISIBLE ACNE - benzoyl peroxide 10% cream 
Cardinal Health

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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Drug Facts

Active ingredient

Benzoyl Peroxide 10%

Purpose

Acne treatment cream

Uses

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

Stop and ask a doctor if

  • too much irritation or sensitiveity develops or increases

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

Aluminum heydroxide gel, Carbomer 940, Glyceryl monostearate, Isopropyl myristate, Magnesium aluminum silicate, Methylparaben, PEG 12, Propylene glycol, Propylparaben, Purified water

Leader Invisible Acne Cream

Maximum Strength

10% Benzoyl Peroxide

tube image

image of tube

Leader Invisible Acne Cream

Maximum Strength

10% Benzoyl Peroxide

carton image

image of carton

LEADER MAXIMUM STRENGTH INVISIBLE ACNE 
benzoyl peroxide 10% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-279
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-279-101 in 1 CARTON
1NDC:37205-279-1128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D06/01/2008
Labeler - Cardinal Health (097537435)
Registrant - Lee Pharmaceuticals (056425432)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health097537435label(37205-279)
Establishment
NameAddressID/FEIBusiness Operations
Lee Pharmaceuticals056425432pack(37205-279)
Establishment
NameAddressID/FEIBusiness Operations
Unipack009248480manufacture(37205-279)

Revised: 9/2012
Document Id: 22632df8-5a39-4cdf-aa7c-c583bd956a74
Set id: 0cef9e55-6e8a-4f9b-a3e0-a4a9fac5bc4a
Version: 4
Effective Time: 20120906
 
Cardinal Health