PROACTIV REPAIRING TREATMENT- benzoyl peroxide gel

Proactiv Repairing Treatment by

Drug Labeling and Warnings

Proactiv Repairing Treatment by is a Otc medication manufactured, distributed, or labeled by Alchemee, LLC, VEE PAK, LLC, kdc/one Chatsworth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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
▪  skin 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.
• cleanse the skin thoroughly before applying this product.
• cover the entire affected area with a thin layer 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, ethoxydiglycol, cyclotetrasiloxane, cyclopentasiloxane, propylene glycol, cetearyl alcohol, dimethicone, glyceryl stearate, PEG-100 stearate, panthenol, allantoin, xanthan gum, ceteareth-20, carbomer, sodium hydroxide, diazolidinyl urea, methylparaben, propylparaben, fragrance

Questions or comments?
Within US 1-800-950-4695

SPL UNCLASSIFIED SECTION

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 - 30 mL Bottle Label

proactiv®                    

3
REPAIRING
TREATMENT

1 FL. OZ. 30 mL

benzoyl peroxide acne medication

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

proactiv®                           

3
REPAIRING
TREATMENT

2 FL. OZ. 60 mL

benzoyl peroxide acne medication

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Label

proactiv® 

3
REPAIRING
TREATMENT

4 FL. OZ. 120 mL

benzoyl peroxide acne medication

PRINCIPAL DISPLAY PANEL - 89 mL Carton

proactiv® 

3
REPAIRING
TREATMENT

3 FL. OZ. 89 mL

benzoyl peroxide acne medication

INGREDIENTS AND APPEARANCE

PROACTIV REPAIRING TREATMENT 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-040
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 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
PANTHENOL (UNII: WV9CM0O67Z)
ALLANTOIN (UNII: 344S277G0Z)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
Carboxypolymethylene (UNII: 0A5MM307FC)
TROLAMINE (UNII: 9O3K93S3TK)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
Sodium Hydroxide (UNII: 55X04QC32I)
Cyclomethicone 4 (UNII: CZ227117JE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-040-00	30 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2011
2	NDC: 11410-040-15	60 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2011
3	NDC: 11410-040-30	1 in 1 BOX	11/01/2011
3		89 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
4	NDC: 11410-040-25	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/01/2011

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	11/01/2011

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-040)