PROACTIV SOOTHING SHAVE GEL- benzoyl peroxide gel

Proactiv Soothing Shave Gel by

Drug Labeling and Warnings

Proactiv Soothing Shave Gel by is a Otc medication manufactured, distributed, or labeled by THE PROACTIV COMPANY LLC, VEE PAK, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Benzoyl peroxide 2.5%

Purpose

Acne treatment gel

Use

for the management of acne                 

Warnings

For external use only

When using this product

• do not use this product more than three times per day.
• 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

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.
• apply a small amount to dampened skin.
• cover the entire affected area with a thin layer and rinse thoroughly one to three times daily.
• 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 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.

Inactive ingredients

water, sodium cocoyl isethionate, glycerin, lauryl/myristyl benzoate, coconut acid, linoleic acid, linolenic acid, menthol, butylene glycol, dimethicone, ethylhexylglycerin, acrylates/C10-30 alkyl acrylate crosspolymer, sodium isethionate, sodium hydroxide, 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
Within US 1-800-950-4695 ● proactiv.com
Made in the USA of Foreign and Domestic Components
Proactiv is a trademark of The Proactiv Company Sàrl.

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PRINCIPAL DISPLAY PANEL - 177.4 mL

proactiv®
Soothing Shave Gel
6 FL. OZ.  177.4 mL
benzoyl peroxide acne medication

INGREDIENTS AND APPEARANCE

PROACTIV SOOTHING SHAVE GEL 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-038
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Sodium Cocoyl Isethionate (UNII: 518XTE8493)
Glycerin (UNII: PDC6A3C0OX)
Lauryl/Myristyl Benzoate (UNII: N5RS934G6D)
Coconut Acid (UNII: 40U37V505D)
Linoleic Acid (UNII: 9KJL21T0QJ)
Linolenic Acid (UNII: 0RBV727H71)
Menthol (UNII: L7T10EIP3A)
Butylene Glycol (UNII: 3XUS85K0RA)
Dimethicone (UNII: 92RU3N3Y1O)
Ethylhexylglycerin (UNII: 147D247K3P)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Sodium Isethionate (UNII: 3R36J71C17)
Sodium Hydroxide (UNII: 55X04QC32I)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-038-00	1 in 1 CARTON	04/01/2017
1		177.4 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	04/01/2017

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-038)