X OUT SPOT CORRECTOR- sulfur lotion

X Out Spot Corrector by

Drug Labeling and Warnings

X Out Spot Corrector by is a Otc medication manufactured, distributed, or labeled by THE PROACTIV COMPANY LLC, VEE PAK, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sulfur 6%

Purpose

Acne treatment cream

Use

for the management of acne.

Warnings

For external use only

When using this product

• do not use this product more than three times per day.
• skin irritation and dryness are 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.
• avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Do not use on

• broken skin
• large areas of the skin

Stop use and ask a doctor

If irritation becomes severe.

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

Directions

• Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.
• cleanse 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

water, dicaprylyl carbonate, alcohol denat., neopentyl glycol diheptanoate, glycerin, acacia senegal gum, olive oil PEG-7 esters, butylene glycol, tocopheryl acetate, melaleuca alternifolia (tea tree) leaf oil, cymbopogon schoenanthus extract, geranium maculatum extract, camellia sinensis leaf extract, dipotassium glycyrrhizate, montmorillonite, pentylene glycol, ascorbyl palmitate, ethylhexylglycerin, butyl avocadate, allantoin, glyceryl acrylate/acrylic acid copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, disodium EDTA, sodium hydroxide, ethoxydiglycol, hydroxyphenyl propamidobenzoic acid, phenoxyethanol, methylparaben, ethylparaben, propylparaben, fragrance.

Questions or comments?

Within US 1-800-524-7952

SPL UNCLASSIFIED SECTION

Distributed by The Proactive Company LLC ● 100 N Sepulveda Blvd., El Segundo, CA 90245
Made in the USA of Foreign and Domestic Components ● Xout.com

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

X®
OUT

SPOT CORRECTOR

From the Makers of Proactiv®

sulfur acne treatment
1.0 FL. OZ. 30 mL

INGREDIENTS AND APPEARANCE

X OUT SPOT CORRECTOR 
sulfur lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-063
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
ALCOHOL (UNII: 3K9958V90M)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
GLYCERIN (UNII: PDC6A3C0OX)
ACACIA (UNII: 5C5403N26O)
Olive Oil (UNII: 6UYK2W1W1E)
Butylene Glycol (UNII: 3XUS85K0RA)
.alpha.-tocopherol Acetate (UNII: 9E8X80D2L0)
Tea Tree Oil (UNII: VIF565UC2G)
Cymbopogon Schoenanthus Top (UNII: 9SJI1LW39W)
Geranium Maculatum Root (UNII: 93IXI5B6OJ)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Montmorillonite (UNII: A585MN1H2L)
Pentylene Glycol (UNII: 50C1307PZG)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Ethylhexylglycerin (UNII: 147D247K3P)
Avocado Oil (UNII: 6VNO72PFC1)
Allantoin (UNII: 344S277G0Z)
Acrylic Acid (UNII: J94PBK7X8S)
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium Hydroxide (UNII: 55X04QC32I)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylparaben (UNII: A2I8C7HI9T)
Ethylparaben (UNII: 14255EXE39)
Propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-063-11	1 in 1 BOX	09/14/2017
1		30 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	09/14/2017

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - VEE PAK, LLC (874763303)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-063)