![X-OUT WASH-IN TREATMENT (BENZOYL PEROXIDE) GEL [THE PROACTIV COMPANY LLC]](https://medic.hrt.org//dailymed/images/9668f055-7b27-47d0-8021-8d452173219e/DT.LAB037_X Out Wash-In Treatment 7oz_120716.jpg)
- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Purpose
- Use
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Warnings
For external use only
When using this product
- do not use this product more than three times per day.
- 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 unnecessary sun exposure and use a sunscreen.
- avoid contact with eyes, lips, and mouth.
- avoid contact with hair and dyed fabrics, which may be bleached by this product.
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
Do not use if you
- have very sensitive skin
- are sensitive to benzoyl peroxide
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Directions
- 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 below.
- 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.
- if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
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Inactive Ingredients
Water, Sodium Cocoyl Isethionate, Glycerin, Paraffin, Lauryl/Myristyl Benzoate, Coconut Acid, Linoleic Acid, Linolenic Acid, Menthol, Sodium Isethionate, Butylene Glycol, Dimethicone, Ethylhexylglycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Phenoxyethanol, Fragrance.
Questions or comments?
Within US 1-800-524-7952Distributed by The Proactiv Company, LLC.
100 N Sepulveda Blvd., El Segundo, CA 90245
XOut.com ● Made in the USA of foreign and domestic components.
X Out is a trademark of The Proactiv Company Sàrl. - PRINCIPAL DISPLAY PANEL - 200 g Bottle Label
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INGREDIENTS AND APPEARANCE
X-OUT WASH-IN TREATMENT
benzoyl peroxide gelProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-060 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM) Benzoyl Peroxide 8.5 g in 100 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493) GLYCERIN (UNII: PDC6A3C0OX) Paraffin (UNII: I9O0E3H2ZE) Lauryl/myristyl Benzoate (UNII: N5RS934G6D) Coconut Acid (UNII: 40U37V505D) Linoleic Acid (UNII: 9KJL21T0QJ) Linolenic Acid (UNII: 0RBV727H71) Menthol (UNII: L7T10EIP3A) Sodium Isethionate (UNII: 3R36J71C17) Butylene Glycol (UNII: 3XUS85K0RA) Dimethicone (UNII: 92RU3N3Y1O) Ethylhexylglycerin (UNII: 147D247K3P) Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO) Sodium Hydroxide (UNII: 55X04QC32I) Phenoxyethanol (UNII: HIE492ZZ3T) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11410-060-49 200 g in 1 BOTTLE; Type 0: Not a Combination Product 08/08/2017 12/31/2019 2 NDC:11410-060-10 1 in 1 CARTON 08/06/2019 2 10 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:11410-060-15 200 g in 1 TUBE; Type 0: Not a Combination Product 09/01/2019 4 NDC:11410-060-00 75 g in 1 BOTTLE; Type 0: Not a Combination Product 08/08/2017 12/31/2019 5 NDC:11410-060-05 1 in 1 CARTON 06/01/2019 5 75 g 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 08/08/2017 Labeler - THE PROACTIV COMPANY LLC (080216357) Establishment Name Address ID/FEI Business Operations VEE PAK, LLC 874763303 manufacture(11410-060)
