Leader Maximum Strength Invisible Acne

Dosage form: cream
Ingredients: BENZOYL PEROXIDE 100mg in 1g
Labeler: Cardinal Health
NDC Code: 37205-279

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 Facts

Active ingredient

Benzoyl Peroxide 10%

Purpose

Acne treatment cream

Uses
  • treats acne
  • dries up acne pimples
  • helps prevent new acne pimples

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
  • 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
  • keep tightly closed
  • keep away from heat

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

Leader Invisible Acne Cream

Maximum Strength

10% Benzoyl Peroxide

carton image

LEADER MAXIMUM STRENGTH INVISIBLE ACNE 
benzoyl peroxide 10% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-279
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (BENZOYL PEROXIDE) BENZOYL PEROXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
ALUMINUM HYDROXIDE 
CARBOMER HOMOPOLYMER TYPE C 
GLYCERYL MONOSTEARATE 
ISOPROPYL MYRISTATE 
MAGNESIUM ALUMINUM SILICATE 
METHYLPARABEN 
POLYETHYLENE GLYCOL 600 
PROPYLENE GLYCOL 
PROPYLPARABEN 
WATER 
Packaging
#Item CodePackage Description
1NDC:37205-279-101 TUBE 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/FEIOperations
Cardinal Health097537435label(37205-279)
Establishment
NameAddressID/FEIOperations
Lee Pharmaceuticals056425432pack(37205-279)
Establishment
NameAddressID/FEIOperations
Unipack009248480manufacture(37205-279)

Revised: 09/2012
 
Cardinal Health

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.

Hide
(web3)