CLEAR ZIT- acne treatment cream 
Sheffield Pharmaceuticals LLC

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 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

Principal display panel -  1.0 oz Tube label

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

Principlay Display panel -1.0 oz Carton label

CLEAR ZIT 
acne treatment cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11527-060
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11527-060-341 in 1 CARTON03/08/201004/30/2021
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/03/200304/30/2021
Labeler - Sheffield Pharmaceuticals LLC (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Sheffield Pharmaceuticals LLC151177797manufacture(11527-060)

Revised: 9/2022
 
Sheffield Pharmaceuticals LLC