X OUT DAILY BODY SCRUB- salicylic acid cream
Alchemee, LLC

Disclaimer: 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.

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X Out Daily Body Scrub

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.

DT.LAB038_X Out Daily Body Scrub 4oz_010516 FDA.jpg

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

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11410-059-79	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2017	09/30/2019
2	NDC:11410-059-40	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/28/2017	09/30/2019
3	NDC:11410-059-10	1 in 1 CARTON	02/01/2020	02/03/2020
3		10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	09/28/2017	02/03/2020

Labeler - Alchemee, LLC (080216357)

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

Revised: 12/2022

Document Id: 4eaec7c1-6d3f-43c9-9899-a256def0a0a4

Set id: cde33fe0-f793-4a7e-949b-9d982cab5172

Version: 3

Effective Time: 20221222

Alchemee, LLC