PROACTIV REFINING MASK- sulfur cream

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, 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.
Inactive ingredients

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

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 the USA of Foreign and Domestic Components
Proactiv is a trademark of The Proactiv Company Sàrl.
PRINCIPAL DISPLAY PANEL - 100 g Tube Label

proactiv®

REFINING
MASK

3.5 OZ. 100 g

sulfur acne medication

INGREDIENTS AND APPEARANCE

PROACTIV REFINING MASK
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-507
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	0.06 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ZINC OXIDE (UNII: SOI2LOH54Z)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
LINOLENIC ACID (UNII: 0RBV727H71)
TEA TREE OIL (UNII: VIF565UC2G)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
Glycereth-26 (UNII: NNE56F2N14)
Cymbopogon Schoenanthus Top (UNII: 9SJI1LW39W)
Geranium Maculatum Root (UNII: 93IXI5B6OJ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 11410-507-36	100 g in 1 TUBE; Type 0: Not a Combination Product	12/01/1998

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	12/01/1998

Labeler - THE PROACTIV COMPANY LLC (080216357)

Name	Address	ID/FEI	Business Operations
Establishment
VEE PAK, LLC		874763303	manufacture(11410-507)

PROACTIV REFINING MASK- sulfur cream

Proactiv Refining Mask by

Drug Labeling and Warnings

Drug Details [pdf]