CORRECT AND PERFECT SPOT TREATMENT- sulfur cream

Correct and Perfect Spot Treatment by

Drug Labeling and Warnings

Correct and Perfect Spot Treatment by is a Otc medication manufactured, distributed, or labeled by Dr. Dennis Gross Skincare, LLC, Bentley Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredients

Colloidal Sulfur 3.25%

Purpose

Acne Treatment

Uses

• for the treatment and management of acne

Warnings

For external uses only

When using this product

• do not get into eyes
• do not use on broken skin
• using other topical acne medications 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 over the entire affected area 1-3 times daily
• if bothersome dryness occurs, reduce application to once a day or every other day

Inactive ingredients

1,2-Hexanediol, Bentonite, Bisabolol, Butylene Glycol, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Disodium EDTA, Epilobium Angustifolium Flower/Leaf/Stem Extract, Farnesol, Glycerin, Glyceryl Oleate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Iron Oxides (CI 77491, CI 77492, CI 77499), Kaolin, Magnesium Aluminum Silicate, Menthol, Pentylene Glycol, Phytic Acid, Polysorbate 60, Potassium Sorbate, Propylene Glycol, Pueraria Lobata Root Extract, Quercetin Caprylate, Silica Dimethyl Silylate, Sodium Benzoate, Sodium Gluconate, Squalane, Stearyl Alcohol, Titanium Dioxide (CI 77891), Tropolone, Water (Aqua), Xanthan Gum

PRINCIPAL DISPLAY PANEL - 15g Tube Carton

Dr Dennis Gross

ACNE
SOLUTIONS

SKINCARE

correct &
perfect spot
treatment

sulfur acne
treatment cream

Net Wt 0.5 oz/15g e

INGREDIENTS AND APPEARANCE

CORRECT AND PERFECT SPOT TREATMENT 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58633-223
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	32.5 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
KAOLIN (UNII: 24H4NWX5CO)
BENTONITE (UNII: A3N5ZCN45C)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)
MENTHOL (UNII: L7T10EIP3A)
FYTIC ACID (UNII: 7IGF0S7R8I)
SQUALANE (UNII: GW89575KF9)
XANTHAN GUM (UNII: TTV12P4NEE)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
LEVOMENOL (UNII: 24WE03BX2T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
FARNESOL (UNII: EB41QIU6JL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
GLYCERIN (UNII: PDC6A3C0OX)
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)
EPILOBIUM ANGUSTIFOLIUM FLOWERING TOP (UNII: 08H094218D)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SODIUM GLUCONATE (UNII: R6Q3791S76)
POLYSORBATE 60 (UNII: CAL22UVI4M)
TROPOLONE (UNII: 7L6DL16P1T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL OLEATE (UNII: 4PC054V79P)
QUERCETIN CAPRYLATE (UNII: 3U3074427O)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58633-223-10	1 in 1 CARTON	09/05/2006	12/01/2024
1		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	09/05/2006

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

Establishment
Name	Address	ID/FEI	Business Operations
Bentley Laboratories, LLC		068351753	MANUFACTURE(58633-223)