Label: X OUT CLEANSING BODY BAR- salicylic acid soap
- NDC Code(s): 11410-007-37
- 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.
Updated January 4, 2013
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- Active ingredient
Salicylic Acid 1%Close
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.
- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
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 stated above.
- Inactive ingredients
sodium cocoyl isethionate, stearic acid, water, sodium isethionate, fragrance, cocamidopropyl hydroxysultaine, sodium chloride, galactoarabinan, polyethylene, disodium EDTA, pentasodium pentetate, titanium dioxide (CI 77891)Close
- 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 - 141 g Applicator Carton
From the Makers of Proactiv®
salicylic acid acne treatment
5.0 OZ. • 141 g
- INGREDIENTS AND APPEARANCE
X OUT CLEANSING BODY BAR
salicylic acid soap
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-007 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 1 mg in 100 g Inactive Ingredients Ingredient Name Strength SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) SODIUM ISETHIONATE (UNII: 3R36J71C17) COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W) SODIUM CHLORIDE (UNII: 451W47IQ8X) HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) EDETATE DISODIUM (UNII: 7FLD91C86K) PENTASODIUM PENTETATE (UNII: 961TOZ5L7T) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-007-37 1 in 1 CARTON 1 141 g in 1 APPLICATOR 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)