PROACTIV REFINING MASK- sulfur cream 
Alchemee, 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 Solution Refining 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, 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

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

Proactiv Refining Mask Tube
PROACTIV REFINING MASK 
sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-507
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70) Sulfur0.06 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-507-36100 g in 1 TUBE; Type 0: Not a Combination Product12/01/199808/13/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D12/01/199808/13/2019
Labeler - Alchemee, LLC (080216357)
Establishment
NameAddressID/FEIBusiness Operations
VEE PAK, LLC874763303manufacture(11410-507)

Revised: 12/2022
Document Id: 68235f4d-ae65-47ee-a87b-f2fb6570a6e5
Set id: bda1f6ef-0b5a-4378-9dd9-443a5f341873
Version: 7
Effective Time: 20221216
 
Alchemee, LLC