Drug Facts264  264.005/264AI rev 1

Drug Facts264  264.005/264AI rev 1

Drug Labeling and Warnings

Drug Details

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ACNE CLEANSER- benzoyl peroxide cream 
Old East Main Co.

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
264  264.005/264AI rev 1

Active ingredient

Benzoyl peroxide 10%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Do not use

if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When using this product 

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips and mouth
  • avoid contact with hair and dyed fabrics, which may be bleaced by this product
  • skin irritation may occur, characterized by redness, burning, itching, peeling or possible swelling.  Irritation may be reduced by using the product less frequently or in a lower concentration

Stop use and ask a doctor if

irritation becomes severe

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.  Avoid contact with eyes.  If contact occurs, flush thoroughly with water.

Directions

  • wet face. Gently massage all over face for 20-30 seconds avoiding the eyes.   Rinse thoroughly and pat dry.
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce daily application to once a day or every other day
  • if going outside, apply sunscreen after using this product.  If irritation or sensitivity develops stop use of both products and ask a doctor
  • Sensitivity Test for a New User.  Apply product sparingly to one or two small affected areas, during the first 3 days.  If no discomfort occurs, follow the directions stated above.

Other information

  • keep tightly closed
  • store at room temperature (59⁰-77⁰)

Inactive ingredients

water, cetyl alcohol, petrolatum, acrylates/C10-30 alkyl acrylate crosspolymer, zinc lactate, steareth-2, glycerin, potassium cetyl phosphate, xanthan gum, benzyl alcohol, fragrance, disodium EDTA, laureth-4, BHT, sodium hydroxide, lactic acid, menthol

Adverse reaction

*This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Clean & Clear Continuous Control Acne Cleanser

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE

GOODLETTSVILLE, TN 37072

100% Satisfaction Guaranteed! (888) 309-9030

PRINCIPL DISPLAY PANEL

STUDIO

SELECTION

ACNE 

CONTROL

CLEANSER

ACNE

MEDICATION

BENZOYL PEROXIDE 10%

Compare to Clean & Clear

Continuous Control Acne Cleanser

  • Provides daily control
  • Cleanser for acne prone skin

Helps fight blemishes

NET WT 5 OZ (141 g)

image description

ACNE CLEANSER 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 55910-264
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE104 mg  in 10 g
Inactive Ingredients
Ingredient NameStrength
water (UNII: 059QF0KO0R)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PETROLATUM (UNII: 4T6H12BN9U)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
ZINC LACTATE (UNII: 2GXR25858Y)  
STEARETH-2 (UNII: V56DFE46J5)  
GLYCERIN (UNII: PDC6A3C0OX)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
xanthan gum (UNII: TTV12P4NEE)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
LAURETH-4 (UNII: 6HQ855798J)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
LACTIC ACID (UNII: 33X04XA5AT)  
MENTHOL (UNII: L7T10EIP3A)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 55910-264-56141 g in 1 TUBE; Type 0: Not a Combination Product02/18/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/18/2014
Labeler - Old East Main Co. (068331990)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(55910-264)

Revised: 3/2020
 
Old East Main Co.


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