OTC Medication Information: X Out Daily Body Scrub

X OUT DAILY BODY SCRUB- salicylic acid cream
THE PROACTIV COMPANY 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.

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

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.

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(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Salicylic Acid (Salicylic Acid) Salicylic Acid 2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
Water
Cocamidopropyl Betaine
Paraffin
Distearyl Phthalamic Acid
Cetyl Alcohol
Stearyl Alcohol
Sodium Chloride
Sodium Methyl Cocoyl Taurate
Green Tea Leaf
Aloe Vera Leaf
Menthol
Butylene Glycol
Hexylene Glycol
Caprylyl Glycol
Peg-120 Methyl Glucose Dioleate
Isopropyl Alcohol
Sodium Sulfite
Sodium Benzoate
Edetate Disodium
Coconut Acid
Ascorbic Acid
Ethylhexylglycerin
Sodium Hydroxide
Citric Acid Monohydrate
Phenoxyethanol
Potassium Sorbate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11410-059-79 240 mL in 1 BOTTLE None
2 NDC:11410-059-40 120 mL in 1 BOTTLE None
3 NDC:11410-059-10 1 TUBE in 1 CARTON contains a TUBE
3 10 mL in 1 TUBE This package is contained within the CARTON (11410-059-10)
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 Operations
VEE PAK, LLC 874763303 manufacture (11410-059)

Revised: 01/2018 THE PROACTIV COMPANY LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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