Your browser does not support JavaScript! X OUT SPOT CORRECTOR (SULFUR) LOTION [GUTHY-RENKER LLC]
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X OUT SPOT CORRECTOR (sulfur) lotion
[Guthy-Renker LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

Principal Display Panel - 30 mL Tube Carton
X OUT SPOT CORRECTOR 
sulfur lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11410-006
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SULFUR (SULFUR) SULFUR6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DICAPRYLYL CARBONATE 
MONTMORILLONITE 
ALCOHOL 
NEOPENTYL GLYCOL DIHEPTANOATE 
GLYCERIN 
ACACIA 
TROLAMINE 
BUTYLENE GLYCOL 
DIETHYLENE GLYCOL MONOETHYL ETHER 
GREEN TEA LEAF 
CYMBOPOGON SCHOENANTHUS TOP 
GERANIUM MACULATUM ROOT 
TEA TREE OIL 
GLYCYRRHIZINATE DIPOTASSIUM 
HYDROXYPHENYL PROPAMIDOBENZOIC ACID 
.ALPHA.-TOCOPHEROL ACETATE 
ALLANTOIN 
PENTYLENE GLYCOL 
ETHYLHEXYLGLYCERIN 
BUTYL OLEATE 
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) 
EDETATE DISODIUM 
BUTYLPARABEN 
ETHYLPARABEN 
ISOBUTYLPARABEN 
METHYLPARABEN 
PHENOXYETHANOL 
PROPYLPARABEN 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-006-111 in 1 BOX
130 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D12/31/2012
Labeler - Guthy-Renker LLC (608315453)

Revised: 1/2013
 
Guthy-Renker LLC

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