X Out Spot Corrector by Guthy-Renker LLC X® Out Spot Corrector

X Out Spot Corrector by

Drug Labeling and Warnings

X Out Spot Corrector by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

X OUT SPOT CORRECTOR- sulfur lotion 
THE PROACTIV COMPANY LLC

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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X® Out Spot Corrector

Drug Facts

Active ingredient

Sulfur 6%

Purpose

Acne treatment

Use

for the management of acne.

Warnings

For external use only

When using this product

• 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.

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

• apply a small amount to dampened skin.
• cover the entire affected area with a thin layer and rinse thoroughly 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.
• 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 above.

Inactive ingredients

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

Questions or comments?

Within US 1-800-524-7952

Dist. by: Guthy-Renker® LLC PO Box 14383 Palm Desert, CA 92255-4383

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

X OUT SPOT CORRECTOR 
sulfur lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-006
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)
MONTMORILLONITE (UNII: A585MN1H2L)
ALCOHOL (UNII: 3K9958V90M)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
GLYCERIN (UNII: PDC6A3C0OX)
ACACIA (UNII: 5C5403N26O)
TROLAMINE (UNII: 9O3K93S3TK)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)
TEA TREE OIL (UNII: VIF565UC2G)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BUTYL OLEATE (UNII: 487I65419Q)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-006-11	1 in 1 BOX	12/31/2012	12/31/2019
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	12/31/2012	12/31/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2013

Document Id: 3ad6d4c9-620a-409b-840f-e3ed969cede9

34390-5

Set id: 8cf2e7e3-6a7f-4374-8030-19b39bfd8bad

Version: 2

Effective Time: 20130104