CLEAR ZIT- acne treatment cream

Clear Zit by

Drug Labeling and Warnings

Clear Zit by is a Otc medication manufactured, distributed, or labeled by Sheffield Pharmaceuticals LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzoyl Peroxide 10%

Purpose

Acne Medication

Uses

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

Warnings

When using this product, avoid unnecessary sun exposure and use a sunscreen.

For extrernal use only

Do not use

• if you have very sensative skin or are sensative to benzoyl peroxide
• if you are allergic to any of the ingredients
• on broken skin
• over large areas of the body

When using this product

• apply to affected areas only
• avoid contact with the eyes, lips and mouth
• this product may bleach hair or dyed fabrics
• using other topical acne drugs at the same time or right after use of theis product may increase dryness or irration of the skin. Only one drug should be used unless directed by a doctor.
• This product may cause irratation, charaterized by redness, burning ,itching, peeling or possible swelling.

Stop use and consult a doctor if

skin irritation or sensativity develops or becomes severe

Keep this and all drugs out of the reach of children.

Other information

• Store at a controlled room temperature 68° - 77°F ( 20°-25°C)

Directions

• clean the skin throughly before applying medication
• 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 to once a day or evey other day
• If going outside , use a sunscreen. Allow benzoyl peroxide t dry then follow directions in the sunscreen labeling. If sensativitiy devleops , discontinue use of both products and consult a doctor.

Inactive Ingredients

Aluminium Hydroxide, Carbomer, Glyceral Sterate, Isopropyl Myristate, Magnesium Aluminum Silicate, Methyl Paraben, PEG-12, Proylene Glycol, Propyl Paraben and Purified Water

Questions? 1-800-222-1087

Principal display panel -  1.0 oz Tube

Dr. Sheffield                                                             NDC: 11527-060-34

Maximum Strength                                                  NET WT. 1 oz ( 28g)

10% Benzoyl Peroxide

Acne Treatment Cream

Principlay Display panel -1.0 oz Carton

Dr. Sheffield                                                       NDC: 11527-060-34

Clear-Zit                                                            Made in the USA

Acne Treatment Cream                                     Maximum Strength

                                                                        10% Benzoyl Peroxide

INGREDIENTS AND APPEARANCE

CLEAR ZIT 
acne treatment cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11527-060
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
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)
CARBOMER 940 (UNII: 4Q93RCW27E)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11527-060-34	1 in 1 CARTON	03/08/2010
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	02/03/2003

Labeler - Sheffield Pharmaceuticals LLC (151177797)

Establishment
Name	Address	ID/FEI	Business Operations
Sheffield Pharmaceuticals LLC		151177797	manufacture(11527-060)