X OUT SPOT CORRECTOR- sulfur lotion 
Guthy-Renker 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

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

Principal Display Panel - 30 mL Tube Carton
X OUT SPOT CORRECTOR 
sulfur lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-006
Route of Administration TOPICAL DEA Schedule     
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
1 30 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 12/31/2012
Labeler - Guthy-Renker LLC (608315453)

Revised: 1/2013
Document Id: 57eaad0a-1abf-410d-9654-251a75856d84
Set id: 8cf2e7e3-6a7f-4374-8030-19b39bfd8bad
Version: 1
Effective Time: 20130104
 
Guthy-Renker LLC