X Out Daily Body Scrub by Guthy-Renker LLC X® Out Daily Body Scrub

Drug Details [pdf]

X OUT DAILY BODY SCRUB- salicylic acid lotion
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.

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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 to once a day or every other day.

Inactive ingredients

water, cocamidopropyl betaine, polyethylene, distearyl phthalic acid amide, cetyl alcohol, stearyl alcohol, ammonium laureth sulfate, sodium chloride, camellia sinensia leaf extract, aloe vera leaf juice, menthol, butylene gylcol, PEG-120 methyl glucose dioleate, sodium hydroxide, disodium EDTA, butylparaben, ethylparaben, isobutylparaben, methylparaben, phenoxyethanol, propylparaben, fragrance.

Questions or comments?

Within US 1-800-950-4465

Dist. by: Guthy-Renker® LLC PO Box 14383 Palm Desert, CA 92255-4383

PRINCIPAL DISPLAY PANEL - 240 mL Bottle Label

X®
OUT

DAILY
BODY SCRUB

From the Makers of Proactiv®

salicylic acid acne treatment
8 FL. OZ. 240 mL

Principal Display Panel - 240 mL Bottle Label

X OUT DAILY BODY SCRUB
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-004
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)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
DISTEARYL PHTHALAMIC ACID (UNII: 5552GSZ9LI)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MENTHOL (UNII: L7T10EIP3A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ETHYLPARABEN (UNII: 14255EXE39)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 11410-004-48	120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/31/2012	12/31/2019
2	NDC: 11410-004-80	240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/31/2012	12/31/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part333D	12/31/2012	12/31/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 1/2013

Document Id: ef1081ab-3652-420c-aa86-6c3bc787c980

Set id: 3a339015-32e8-48fc-9931-e1e03b1c3485

Version: 2

Effective Time: 20130102