Proactiv® Skin Purifying Mask

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. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV SKIN PURIFYING MASK- sulfur lotion 
The Proactiv Company, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Proactiv® Skin Purifying Mask

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, 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

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton

proactiv®

SKIN
PURIFYING
MASK

3 OZ. 85 g

sulfur acne medication

PRINCIPAL DISPLAY PANEL - 85 g Tube Carton
PROACTIV SKIN PURIFYING MASK 
sulfur lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-015
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 (1800 MW) (UNII: 248P1AUJ90)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
LINOLENIC ACID (UNII: 0RBV727H71)  
CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)  
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)  
TEA TREE OIL (UNII: VIF565UC2G)  
TOCOPHEROL (UNII: R0ZB2556P8)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
HYDRATED SILICA (UNII: Y6O7T4G8P9)  
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM SULFATE (UNII: 0YPR65R21J)  
EDETATE SODIUM (UNII: MP1J8420LU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11410-015-961 in 1 CARTON03/08/201606/30/2019
185 g in 1 TUBE; Type 0: Not a Combination Product
2NDC: 11410-015-291 in 1 CARTON03/08/201606/30/2019
228 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D03/08/201606/30/2019
Labeler - The Proactiv Company, LLC (080216357)
Registrant - VEE PAK, LLC (874763303)

Revised: 3/2017
 
The Proactiv Company, LLC