CLARIFYING COLLOIDAL SULFUR MASK- sulfur cream 
Dr. Dennis Gross Skincare, LLC

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Clarifying Colloidal Sulfur Mask

DRUG FACTS

Active Ingredient

Colloidal Sulfur 5.0%

Purpose

Acne Treatment

Indications

  • for the treatment and management of acne
  • penetrates pore to eliminate most acne blemishes and blackheads
  • helps prevent development of new acne blemishes and blackheads

Warnings

For external use only

When using this product

  • do not get into eyes
  • do not use on broken skin
  • using topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used until directed by a doctor

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • cleanse the skin thoroughly before applying
  • apply a thin layer to the affected area 1-3 times daily. Leave on for at least 10 minutes, then rinse.
  • for AM use as a mattifier under makeup, apply a tiny amount and work into skin until it disappears
  • for PM use as a mask 2-3x per week or as needed, apply a thicker layer, wear overnight & wash off in morning
  • suitable for use on face, chest, and back
  • if bothersome dryness occurs, reduce application to once a day or every other day

Inactive ingredients

Allantoin, Aloe Barbadensis Leaf Juice, Bentonite, Bisabolol, Butylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Ethylhexylglycerin, Farnesol, Glycerin, Glyceryl Stearate, Glycine Soja (Soybean) Oil, Glycyrrhiza Glabra (Licorice) Root Extract, Kaolin, Opuntia Tuna Flower/Stem Extract, PEG-100 Stearate, Phenoxyethanol, Phenylethyl Resorcinol, Retinol, Rosmarinus Officinalis (Rosemary) Leaf Oil, Salix Alba (Willow) Bark Extract, Sodium PCA, Tocopheryl Acetate, Water (Aqua), Zinc Oxide

PRINCIPAL DISPLAY PANEL - 50g Jar Carton

ACNE
SOLUTIONS

SKINCARE

clarifying colloidal
sulfur mask

acne medication

Net Wt 1.7oz/50g e

Dr Dennis Gross

Principal Display Panel - 50g Jar Carton
CLARIFYING COLLOIDAL SULFUR MASK 
sulfur cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58633-269
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
sulfur (UNII: 70FD1KFU70) (sulfur - UNII:70FD1KFU70) sulfur50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Kaolin (UNII: 24H4NWX5CO)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Glycerin (UNII: PDC6A3C0OX)  
PEG-100 Stearate (UNII: YD01N1999R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Aloe Vera Leaf (UNII: ZY81Z83H0X)  
Zinc Oxide (UNII: SOI2LOH54Z)  
Bentonite (UNII: A3N5ZCN45C)  
Safflower Oil (UNII: 65UEH262IS)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Opuntia Tuna Flowering Top (UNII: R4AS8333O2)  
Allantoin (UNII: 344S277G0Z)  
Levomenol (UNII: 24WE03BX2T)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Salix Alba Bark (UNII: 205MXS71H7)  
Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
Phenylethyl Resorcinol (UNII: G37UFG162O)  
Glycyrrhiza Glabra (UNII: 2788Z9758H)  
Rosemary Oil (UNII: 8LGU7VM393)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Soybean Oil (UNII: 241ATL177A)  
Farnesol (UNII: EB41QIU6JL)  
Retinol (UNII: G2SH0XKK91)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58633-269-101 in 1 CARTON08/01/201204/01/2023
150 g in 1 JAR; Type 0: Not a Combination Product
2NDC:58633-269-5015 g in 1 JAR; Type 0: Not a Combination Product08/01/201204/01/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00608/01/201204/01/2023
Labeler - Dr. Dennis Gross Skincare, LLC (008190808)
Establishment
NameAddressID/FEIBusiness Operations
PhytogenX010297942MANUFACTURE(58633-269) , PACK(58633-269)

Revised: 7/2013
Document Id: 4f765725-4603-4109-a193-c2c3c16c6641
Set id: c80b1d3d-7065-4e7b-9023-3c0c5b09af49
Version: 2
Effective Time: 20130719
 
Dr. Dennis Gross Skincare, LLC