CONCEALING SPOT TREATMENT- sulfur lotion 
Dermalogica, Inc.

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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Concealing Spot Treatment

Drug Facts

Active ingredient

Sulfur (5.0%)

Purpose

Acne treatment

Indications

Warnings

For external use only

Do not use

  • on broken skin.
  • on large areas of the body.

Using other topical acne medications

  • at the same time or immediately following use of this product may increase dryness or or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

Stop use and ask a doctor

  • if excessive skin irritation develops or increases.

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Inactive ingredients

Hamamelis Virginiana (Witch Hazel) Water, Ethyl Trisiloxane, Butylene Glycol, Silica Dimethyl Silylate, Cetearyl Alcohol, Peg-40 Hydrogenated Castor Oil, Dimethicone, Ceratonia Siliqua (Carob) Seed Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Cinnamomum Zeylanicum Bark Extract, Niacinamide, Yeast Extract, Salicylic Acid, Biotin, Zinc Gluconate, Panthenol, Montmorillonite, Caffeine, Lauryl PEG/PPG-18/18 Methicone, Camphor, Capryloyl Glycine, Sarcosine, Ammonium Glycyrrhizate, Ceteareth-20, Potassium Alum, Water, Xanthan Gum, Ethylhexylglycerin, Phenoxyethanol, Iron Oxides (CI 77492), (CI 77491), (CI 77499), Titanium Dioxide (CI 77891), Zinc Oxide (CI 77947).

Questions or comments?

Call toll free 1-800-831-5150 in the US

PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton

new
improved
formula

concealing
spot
treatment

acne treatment

mediBac clearing®

0.33 US FL OZ
10 mL e

dermalogica®

PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton
CONCEALING SPOT TREATMENT 
sulfur lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
ETHYL TRISILOXANE (UNII: ZH1WJO5481)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HORSE CHESTNUT (UNII: 3C18L6RJAZ)  
CINNAMON BARK OIL (UNII: XE54U569EC)  
NIACINAMIDE (UNII: 25X51I8RD4)  
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
SALICYLIC ACID (UNII: O414PZ4LPZ)  
BIOTIN (UNII: 6SO6U10H04)  
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
PANTHENOL (UNII: WV9CM0O67Z)  
MONTMORILLONITE (UNII: A585MN1H2L)  
CAFFEINE (UNII: 3G6A5W338E)  
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)  
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
SARCOSINE (UNII: Z711V88R5F)  
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
POTASSIUM ALUM (UNII: 1L24V9R23S)  
WATER (UNII: 059QF0KO0R)  
XANTHAN GUM (UNII: TTV12P4NEE)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Product Characteristics
ColorBROWNScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-005-021 in 1 CARTON
110 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:68479-005-013 mL in 1 TUBE; Type 0: Not a Combination Product
3NDC:68479-005-002 mL in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D04/22/2014
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
PakLab790530976MANUFACTURE(68479-005)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes161104729MANUFACTURE(68479-005)

Revised: 11/2015
Document Id: e07cdb00-e54a-411e-9e9d-5e747f9ffc14
Set id: 556fc017-bf95-4ec0-8c1e-ed646c88ef2c
Version: 2
Effective Time: 20151119
 
Dermalogica, Inc.