Label: CLARIFYING COLLOIDAL SULFUR MASK- sulfur cream
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Contains inactivated NDC Code(s)
NDC Code(s): 58633-269-10, 58633-269-50 - Packager: Dr. Dennis Gross Skincare, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated July 19, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Indications
- Warnings
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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
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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
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INGREDIENTS AND APPEARANCE
CLARIFYING COLLOIDAL SULFUR MASK
sulfur creamProduct 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)
