PROACTIV REPAIRING MASK- benzoyl peroxide cream

Proactiv Repairing Mask by

Drug Labeling and Warnings

Proactiv Repairing Mask by is a Otc medication manufactured, distributed, or labeled by THE PROACTIV COMPANY LLC, Vee Pak Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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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

INGREDIENTS AND APPEARANCE

PROACTIV REPAIRING MASK 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)	Benzoyl Peroxide	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-002-94	75 mL in 1 JAR; Type 0: Not a Combination Product	01/24/2018
2	NDC: 11410-002-95	30 mL in 1 JAR; Type 0: Not a Combination Product	01/24/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	01/24/2018

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
Vee Pak Inc.		874763303	MANUFACTURE(11410-002)