Label: X OUT SPOT CORRECTOR- sulfur lotion
- NDC Code(s): 11410-006-11
- Packager: Guthy-Renker LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the 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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- SPL UNCLASSIFIED SECTION
- Active ingredient
for the management of acne.Close
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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
- 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, fragranceClose
- Questions or comments?
Within US 1-800-524-7952Close
- SPL UNCLASSIFIED SECTION
Dist. by: Guthy-Renker® LLC • PO Box 14383 Palm Desert, CA 92255-4383Close
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
From the Makers of Proactiv®
sulfur acne treatment
1.0 FL. OZ. • 30 mL
- INGREDIENTS AND APPEARANCE
X OUT SPOT CORRECTOR
Product Information Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:11410-006 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SULFUR (SULFUR) SULFUR 6 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 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)