LEADER MAXIMUM STRENGTH INVISIBLE ACNE- benzoyl peroxide 10% cream

Leader Maximum Strength Invisible Acne by

Drug Labeling and Warnings

Leader Maximum Strength Invisible Acne by is a Otc medication manufactured, distributed, or labeled by Cardinal Health, Lee Pharmaceuticals, Unipack. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

Leader Invisible Acne Cream

Maximum Strength

10% Benzoyl Peroxide

tube image

Leader Invisible Acne Cream

Maximum Strength

10% Benzoyl Peroxide

carton image

INGREDIENTS AND APPEARANCE

LEADER MAXIMUM STRENGTH INVISIBLE ACNE 
benzoyl peroxide 10% cream

Product 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)