CLARIFYING SPOT WITH SULFUR PLUS GREEN CLAY ACNE MEDICATION- sulfur solution

Clarifying Spot with Sulfur plus Green Clay by

Drug Labeling and Warnings

Clarifying Spot with Sulfur plus Green Clay by is a Otc medication manufactured, distributed, or labeled by Lancer Skincare LLC., Vege-Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Sulfur 10.0%

Purpose

Acne Treatment

Uses

For the management of acne

Warnings

For external use only

Do not use on

• Broken skin
• Large areas of the skin

When using this product

• skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time
• apply only to areas with acne

Keep out of reach of children. If product is swallowed, get medical help or contact a poison control center right away.

Flammable, keep away from fire or flame.

Directions

• clean the skin thoroughly before applying this product
• cover the entire affected area with a thin layer one to three times daily
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
• if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Inactive Ingredients

Alcohol Denat., Water, Azelaic Acid, PVP, Camellia Sinensis Leaf Extract, Salicylic Acid, Papain, Bromelain, Maltodextrin, Glycerin, Magnesium Aluminum Silicate, Disodium Carboxyethyl Siliconate, Illite, Montmorillonite, Kaolin, Calcite, Sodium Hydroxide, Chromium Oxide Greens, Titanium Dioxide

Questions?

1800-899-0744 M-F 9-5PST

SPL UNCLASSIFIED SECTION

Dist. by
LANCER SKINCARE LLC
440 N. Rodeo Dr., 3F
Beverly Hills, CA 90210

PRINCIPAL DISPLAY PANEL - 9 mL Tube Carton

LANCER®

RESEARCHED
AND DEVELOPED
AT
LANCERX™
dermatology
BEVERLY HILLS

UTMOST LUXURY
LANCER SKINCARE
FIRST-CLASS DERMATOLOGY
TRUE EFFICACY

CLARIFYING SPOT
SOLUTION
with 10% Sulfur + Green Clay

0.3 FL.OZ. | 9 mL

INGREDIENTS AND APPEARANCE

CLARIFYING SPOT WITH SULFUR PLUS GREEN CLAY   ACNE MEDICATION
sulfur solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72704-129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)
Water (UNII: 059QF0KO0R)
Azelaic Acid (UNII: F2VW3D43YT)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Salicylic Acid (UNII: O414PZ4LPZ)
Papain (UNII: A236A06Y32)
Bromelains (UNII: U182GP2CF3)
Maltodextrin (UNII: 7CVR7L4A2D)
Glycerin (UNII: PDC6A3C0OX)
Magnesium Aluminum Silicate (UNII: 6M3P64V0NC)
Disodium Carboxyethyl Siliconate (UNII: 4U4C79679G)
Ledikite (UNII: D7BC5B0F46)
Montmorillonite (UNII: A585MN1H2L)
Kaolin (UNII: 24H4NWX5CO)
Calcium Carbonate (UNII: H0G9379FGK)
Sodium Hydroxide (UNII: 55X04QC32I)
Chromic Oxide (UNII: X5Z09SU859)
Titanium Dioxide (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72704-129-01	1 in 1 CARTON	10/15/2021
1		9 mL 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 FINAL	part333D	10/15/2021

Labeler - Lancer Skincare LLC. (079089155)

Establishment
Name	Address	ID/FEI	Business Operations
Vege-Labs		117878620	MANUFACTURE(72704-129)