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

Use

for the treatment of acne.

Warnings

For external use only

Do not use

  • on broken skin
  • on large areas of the body

When using this product,

  • apply to affected areas only.

  • do not use in or near eyes.

  • Stop use and ask a physician if too much skin irritation or sensitivity develops or increases.

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

Directions

  • Dot onto finger and apply to afflicted area.
  • Let stand for five seconds, then pat until blended in.
  • Use until breakout has cleared.

Inactive ingredients

Hamamelis Virginiana (Witch Hazel) Water, Butylene Glycol, Glycerine, Cetearyl Alcohol, Silica, Zinc Oxide, PEG-40 Hydrogenated Castor Oil, Montmorillonite, Ceteareth-20, Xanthan Gum, Niacinamide, Yeast Extract, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Ammonium Glycyrrhizate, Panthenol, Salicylic Acid, Propylene Glycol, Zinc Gluconate, Caffeine, Biotin, Capryloyl Glycine, Sarcosine, Cinnamomum Zeylanicum Bark Extract, Hydrolyzed Ceratonia Siliqua Seed Extract, Water (Aqua), Camphor, Ethylhexylglycerin, Phenoxyethanol, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, 77499, 77492).

Questions?

1-800-831-5150 in USA Monday-Friday 9AM PST to 5PM PST

PRINCIPAL DISPLAY PANEL - 10 mL Tube Carton

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:68479-116
Route of AdministrationTOPICALDEA Schedule    
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)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Glycerin (UNII: PDC6A3C0OX)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Zinc Oxide (UNII: SOI2LOH54Z)  
Polyoxyl 40 Hydrogenated Castor Oil (UNII: 7YC686GQ8F)  
Montmorillonite (UNII: A585MN1H2L)  
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
Xanthan Gum (UNII: TTV12P4NEE)  
Niacinamide (UNII: 25X51I8RD4)  
Yeast (UNII: 3NY3SM6B8U)  
Horse Chestnut (UNII: 3C18L6RJAZ)  
Ammonium Glycyrrhizate (UNII: 3VRD35U26C)  
Panthenol (UNII: WV9CM0O67Z)  
Salicylic Acid (UNII: O414PZ4LPZ)  
Zinc Gluconate (UNII: U6WSN5SQ1Z)  
Caffeine (UNII: 3G6A5W338E)  
Biotin (UNII: 6SO6U10H04)  
Capryloyl Glycine (UNII: 8TY5YO42NJ)  
Sarcosine (UNII: Z711V88R5F)  
Cinnamon Bark Oil (UNII: XE54U569EC)  
Water (UNII: 059QF0KO0R)  
Camphor (Synthetic) (UNII: 5TJD82A1ET)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Titanium Dioxide (UNII: 15FIX9V2JP)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Ferrosoferric Oxide (UNII: XM0M87F357)  
Ferric Oxide Yellow (UNII: EX438O2MRT)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-116-021 in 1 CARTON
110 mL in 1 TUBE
2NDC:68479-116-013 mL in 1 TUBE
3NDC:68479-116-002 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H10/05/201007/03/2014
Labeler - Dermalogica, Inc. (177698560)
Establishment
NameAddressID/FEIBusiness Operations
PakLab790530976MANUFACTURE(68479-116)
Establishment
NameAddressID/FEIBusiness Operations
Diamond Wipes161104729MANUFACTURE(68479-116)

Revised: 3/2015
 
Dermalogica, Inc.