CLARIFYING COLLOIDAL SULFUR MASK- sulfur cream

Clarifying Colloidal Sulfur Mask by

Drug Labeling and Warnings

Clarifying Colloidal Sulfur Mask by is a Otc medication manufactured, distributed, or labeled by Dr. Dennis Gross Skincare, LLC, PhytogenX. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

CLARIFYING COLLOIDAL SULFUR MASK 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58633-269
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
sulfur (UNII: 70FD1KFU70) (sulfur - UNII:70FD1KFU70)	sulfur	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58633-269-10	1 in 1 CARTON
1		50 g in 1 JAR
2	NDC: 58633-269-50	15 g in 1 JAR

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	08/01/2012

Labeler - Dr. Dennis Gross Skincare, LLC (008190808)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX		010297942	MANUFACTURE(58633-269) , PACK(58633-269)