PROACTIV SKIN PURIFYING MASK- sulfur lotion

Proactiv Skin Purifying Mask by

Drug Labeling and Warnings

Proactiv Skin Purifying Mask by is a Otc medication manufactured, distributed, or labeled by THE PROACTIV COMPANY LLC, VEE PAK, LLC, KIK Holdco Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sulfur 6%

Purpose

Acne treatment

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.
• apply only to areas with acne.
• avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

Do not use on

• broken skin
• large areas of the skin

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, follows 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.

Inactive ingredients

water, kaolin, glycereth-26, linoleic acid, cetearyl alcohol, magnesium aluminum silicate, synthetic wax, ceteareth-20, sodium lauroyl sarcosinate, linolenic acid, tocopherol, tocopheryl acetate, melaleuca alternifolia (tea tree) leaf oil, cymbopogon schoenanthus extract, geranium maculatum extract, hydrated silica, ethoxydiglycol, tetrasodium EDTA, sodium sulfate, butylene glycol, phenoxyethanol, fragrance, titanium dioxide, zinc oxide, chromium hydroxide green

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
proactiv.com ● Made in USA of Foreign and Domestic Components

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245
 Manufactured in Canada ● proactiv.com

Proactiv is a trademark of The Proactiv Company Sàrl

PRINCIPAL DISPLAY PANEL - 1 OZ.  28 g

proactiv®              

SKIN
PURIFYING
MASK                  

1 OZ. 28 g
sulfur acne medication

PRINCIPAL DISPLAY PANEL - 3 oz. 85 G

proactiv®    

SKIN
PURIFYING
MASK 

3 OZ. 85 g
sulfur acne medication

INGREDIENTS AND APPEARANCE

PROACTIV SKIN PURIFYING MASK 
sulfur lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
GLYCERETH-26 (UNII: NNE56F2N14)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
Synthetic Wax (1200 Mw) (UNII: Q3Z4BCH099)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Sodium Lauroyl Sarcosinate (UNII: 632GS99618)
Linolenic Acid (UNII: 0RBV727H71)
Tocopherol (UNII: R0ZB2556P8)
.alpha.-tocopherol Acetate (UNII: 9E8X80D2L0)
Tea Tree Oil (UNII: VIF565UC2G)
Cymbopogon Schoenanthus Top (UNII: 9SJI1LW39W)
Geranium Maculatum Root (UNII: 93IXI5B6OJ)
Hydrated Silica (UNII: Y6O7T4G8P9)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
Edetate Sodium (UNII: MP1J8420LU)
Sodium Sulfate (UNII: 0YPR65R21J)
Butylene Glycol (UNII: 3XUS85K0RA)
Phenoxyethanol (UNII: HIE492ZZ3T)
Titanium Dioxide (UNII: 15FIX9V2JP)
Zinc Oxide (UNII: SOI2LOH54Z)
Chromium Hydroxide Green (UNII: RV8FT8XF5R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-013-00	1 in 1 BOX	12/31/2012	05/14/2019
1		30 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11410-013-05	1 in 1 BOX	12/31/2013
2		85 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11410-013-10	1 in 1 BOX	09/01/2019
3		9 g in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 11410-013-02	1 in 1 BOX	12/31/2013
4		28 g in 1 TUBE; 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	12/31/2012

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-013)

Establishment
Name	Address	ID/FEI	Business Operations
KIK Holdco Company Inc		243547333	manufacture(11410-013)