PROACTIV REPAIRING MASK- benzoyl peroxide cream 
Alchemee, 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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Proactiv Repairing Mask

Drug Facts

Active ingredient

Benzoyl peroxide 5.0%

Purpose

Acne treatment gel

Use

for the management of acne                 

Warnings

For external use only

When using this product

  • skin irritation and dryness are 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 bleached by this product.
  • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.

Do not use if you

  • have very sensitive skin
  • are sensitive to benzoyl peroxide
  • are sensitive to coconut

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.

Directions

  • 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 below.
  • Using fingertips, apply a thin layer evenly over the entire face using gentle circular - avoiding the eye area. Allow to sit on face for up to 2 minutes. Rinse thoroughly and pat dry. Use up to two to three times a week or as needed.
  • if bothersome dryness or peeling occurs, reduce application.
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

Water, Sodium Cocoyl Isethionate, Glycerin, Lauryl/Myristyl Benzoate, Coconut Acid, Cocos Nucifera (Coconut) Fruit Extract, Cocos Nucifera (Coconut) Oil, PEG-60 Hydrogenated Castor Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Helianthus Annuus (Sunflower) Seed Oil, Linoleic Acid, Linolenic Acid, Menthol, Sodium Isethionate, Butylene Glycol, Dimethicone, Phenethyl Alcohol, Caprylyl Glycol, Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Potassium Sorbate, Sodium Benzoate, Phenoxyethanol, Fragrance.

Questions or comments?

Within US 1-800-950-4695

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245
proactive.com ● Made in the USA of Foreign and Domestic Components

Proactiv is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 2.5 FL. OZ. 75 mL

proactiv®

Repairing Mask                 

 2.5 FL. OZ. 75 mL                

benzoyl peroxide
acne medication

Repairing_Mask_Label
PROACTIV REPAIRING MASK 
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Sodium Cocoyl Isethionate (UNII: 518XTE8493)  
Lauryl/myristyl Benzoate (UNII: N5RS934G6D)  
Coconut Acid (UNII: 40U37V505D)  
Coconut (UNII: 3RT3536DHY)  
Coconut Oil (UNII: Q9L0O73W7L)  
Peg-60 Hydrogenated Castor Oil (UNII: 02NG325BQG)  
Rosemary (UNII: IJ67X351P9)  
Sunflower Oil (UNII: 3W1JG795YI)  
Linoleic Acid (UNII: 9KJL21T0QJ)  
Linolenic Acid (UNII: 0RBV727H71)  
Menthol (UNII: L7T10EIP3A)  
Sodium Isethionate (UNII: 3R36J71C17)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Dimethicone (UNII: 92RU3N3Y1O)  
Phenylethyl Alcohol (UNII: ML9LGA7468)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-002-9475 mL in 1 JAR; Type 0: Not a Combination Product01/24/201805/02/2018
2NDC:11410-002-9530 mL in 1 JAR; Type 0: Not a Combination Product01/24/201805/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D01/24/201805/02/2018
Labeler - Alchemee, LLC (080216357)
Establishment
NameAddressID/FEIBusiness Operations
Vee Pak Inc.874763303MANUFACTURE(11410-002)

Revised: 12/2022
 
Alchemee, LLC