MARY KAY ACNE TREATMENT ACNE MEDICATION- benzoyl peroxide gel 
Mary Kay Inc.

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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Mary Kay Acne Treatment Gel
Drug Facts

Active ingredient:


Benzoyl Peroxide 5%

Purpose


Acne Medication

Uses


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

Other information


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 Type HUMAN OTC DRUG Item Code (Source) NDC:51531-0813
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 5 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
Water (UNII: 059QF0KO0R)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Poloxamer 182 (UNII: JX0HIX6OAG)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Docusate Sodium (UNII: F05Q2T2JA0)  
Edetate Disodium (UNII: 7FLD91C86K)  
Glycerin (UNII: PDC6A3C0OX)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Echinacea Purpurea (UNII: QI7G114Y98)  
Cucumber (UNII: YY7C30VXJT)  
Horse Chestnut (UNII: 3C18L6RJAZ)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51531-0813-1 1 in 1 CARTON
1 28 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part333D 01/19/1988
Labeler - Mary Kay Inc. (103978839)
Establishment
Name Address ID/FEI Business Operations
Kolmar Laboratories Inc. 001535103 manufacture(51531-0813)

Revised: 1/2013
Document Id: f676f9d0-15ff-4586-919e-c1e08170a27c
Set id: d2d85dd1-6316-4642-9f95-b1c396f99f2b
Version: 3
Effective Time: 20130129
 
Mary Kay Inc.