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Clear Zit

Medically reviewed on June 5, 2017.

Dosage form: cream
Ingredients: BENZOYL PEROXIDE 100mg in 1g
Labeler: Sheffield Pharmaceuticals LLC
NDC Code: 11527-060

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 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

CLEAR ZIT 
acne treatment cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-060
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
WATER 
PROPYLENE GLYCOL 
GLYCERYL MONOSTEARATE 
ALUMINUM HYDROXIDE 
ISOPROPYL MYRISTATE 
MAGNESIUM ALUMINUM SILICATE 
POLYETHYLENE GLYCOL 600 
CARBOMER 940 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:11527-060-341 TUBE in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/03/2003
Labeler - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIOperations
Sheffield Pharmaceuticals LLC151177797manufacture(11527-060)

 
Sheffield Pharmaceuticals LLC

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.

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