CONCEALING SPOT TREATMENT- sulfur lotion

Concealing Spot Treatment by

Drug Labeling and Warnings

Concealing Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc., PakLab, Diamond Wipes. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sulfur (5.0%)

Purpose

Acne treatment

Indications

• For the treatment of acne.

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

• Dot onto finger and apply to cleansed skin.
• Let stand for five seconds, then pat until blended in.
• Use 1-2 times daily until breakout has cleared.

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®

INGREDIENTS AND APPEARANCE

CONCEALING SPOT TREATMENT 
sulfur lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-005
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 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-005-02	1 in 1 CARTON
1		10 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68479-005-01	3 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 68479-005-00	2 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	04/22/2014

Labeler - Dermalogica, Inc. (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
PakLab		790530976	MANUFACTURE(68479-005)

Establishment
Name	Address	ID/FEI	Business Operations
Diamond Wipes		161104729	MANUFACTURE(68479-005)