X OUT DAILY BODY SCRUB- salicylic acid cream

X Out Daily Body Scrub by

Drug Labeling and Warnings

X Out Daily Body Scrub by is a Otc medication manufactured, distributed, or labeled by THE PROACTIV COMPANY LLC, VEE PAK, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic Acid 2%

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.
• avoid contact with eyes.  If contact occurs, rinse eyes thoroughly with water.

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 once a day or every other day.

Inactive Ingredients

Water, Cocamidopropyl Betaine, Paraffin, Distearyl Phthalic Acid Amide, Cetyl Alcohol, Stearyl Alcohol, Sodium Chloride, Sodium Methyl Cocoyl Taurate, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Menthol, Butylene Glycol, Hexylene Glycol, Caprylyl Glycol, PEG-120 Methyl Glucose Dioleate, Isopropyl Alcohol, Sodium Sulfite, Sodium Benzoate, Disodium EDTA, Coconut Acid, Ascorbic Acid, Ethylhexylglycerin, Sodium Hydroxide, Citric Acid, Phenoxyethanol, Potassium Sorbate, Fragrance

Questions or comments?
Within US 1-800-524-7952

PRINCIPAL DISPLAY PANEL - 120 mL Label

X OUT

DAILY
BODY SCRUB 
From the Makers of Proactiv®               

salicylic acid acne treatment
4 FL. OZ. · 120 mL

Distributed 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.

INGREDIENTS AND APPEARANCE

X OUT DAILY BODY SCRUB 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-059
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
Paraffin (UNII: I9O0E3H2ZE)
Distearyl Phthalamic Acid (UNII: 5552GSZ9LI)
Cetyl Alcohol (UNII: 936JST6JCN)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
Sodium Chloride (UNII: 451W47IQ8X)
Sodium Methyl Cocoyl Taurate (UNII: JVL98CG53G)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Menthol (UNII: L7T10EIP3A)
Butylene Glycol (UNII: 3XUS85K0RA)
Hexylene Glycol (UNII: KEH0A3F75J)
Caprylyl Glycol (UNII: 00YIU5438U)
Peg-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)
Isopropyl Alcohol (UNII: ND2M416302)
Sodium Sulfite (UNII: VTK01UQK3G)
Sodium Benzoate (UNII: OJ245FE5EU)
Edetate Disodium (UNII: 7FLD91C86K)
Coconut Acid (UNII: 40U37V505D)
Ascorbic Acid (UNII: PQ6CK8PD0R)
Ethylhexylglycerin (UNII: 147D247K3P)
Sodium Hydroxide (UNII: 55X04QC32I)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Phenoxyethanol (UNII: HIE492ZZ3T)
Potassium Sorbate (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-059-79	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2017
2	NDC: 11410-059-40	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2017
3	NDC: 11410-059-10	1 in 1 CARTON	02/01/2020
3		10 mL 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	09/28/2017

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-059)