Your browser does not support JavaScript! MARY KAY ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]
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MARY KAY ACNE TREATMENT ACNE MEDICATION (benzoyl peroxide) gel
[Mary Kay Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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 Label Sections

Active ingredient:


Benzoyl Peroxide 5%

Purpose


Acne Medication

Uses


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

Warnings

For external use only.

Do not use this product if

  • you have very sensitive skin
  • you are sensitive to benzoyl peroxide
  • on large areas of the body

When using this product

  • avoid unnecessary sun exposure and use sunscreen
  • avoid eyes, lips and mouth
  • this product may bleach hair or dyed fabrics
  • this product may cause irritation
  • using other topical acne medications at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Stop use and ask a doctor if

too much skin irritation or sensitivity develops or increases.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • clean the skin thoroughly before applying.
  • cover the entire affected area with a thin layer one to three times daily.
  • because too much 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 application to once a day or oevery other day.
  • if going outside, use a sunscreen. Allow benzoyl peroxide to dry, then follow directions in the sunscreen labeling.

Other information


  • store at 59F to 86F
  • expiration date on tube crimp

Inactive ingredients

aesculus hippocastanum (horse chestnut) seed extract, butylene glycol, carbomer, cucumis sativus (cucumber) fruit extract, diethylhexyl sodium sulfosuccinate, disodium EDTA, echinacea purpurea extract, glycerin, poloxamer 182, propylene glycol, silica, sodium hydroxide, water.

Principal Display Panel - 28 g carton


Mary Kay
acne treatment gel

acne medication
5% benzoyl peroxide

1 OZ. NET WT./28 g

Image of carton label

MARY KAY ACNE TREATMENT  ACNE MEDICATION
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:51531-0813
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (Benzoyl Peroxide) Benzoyl Peroxide5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Water 
Propylene Glycol 
Poloxamer 182 
Silicon Dioxide 
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
Sodium Hydroxide 
Docusate Sodium 
Edetate Disodium 
Glycerin 
Butylene Glycol 
Echinacea Purpurea 
Cucumber 
Horse Chestnut 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51531-0813-11 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/19/1988
Labeler - Mary Kay Inc. (103978839)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Laboratories Inc.001535103manufacture(51531-0813)

Revised: 1/2013
 
Mary Kay Inc.

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