X® Out Cleansing Wipes For On The Go Blemish Treatment

Drug Labeling and Warnings

Drug Details [pdf]

X OUT CLEANSING WIPES FOR ON THE GO BLEMISH TREATMENT- benzoyl peroxide swab 
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 Cleansing Wipes For On The Go Blemish Treatment

DRUG FACTS

Active ingredient

Benzoyl peroxide 2.5%

Purpose

Acne treatment gel

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 unnecessary sun exposure and use a sunscreen.
  • avoid contact with the 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.

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

  • cleanse the skin thoroughly before applying this product.
  • cover the entire affected area with a thin layer 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.
  • 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 above.
  • if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

water (aqua), caprylic/capric triglyceride, propanediol, methyl methacrylate/glycol dimethacrylate crosspolymer, dimethicone, cyclopentasiloxane, steareth-20, cyclohexasiloxane, glyceryl stearate, PEG-100 stearate, chamomilla recutita (matricaria) flower oil, allantoin, ethylhexylglycerin, panthenol, xanthan gum, cetearyl alcohol, bentonite, citric acid, sodium citrate, disodium EDTA, sodium hydroxide, phenoxyethanol

Questions or comments?

Within the US 1-800-524-7952

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

PRINCIPAL DISPLAY PANEL - 10 Swab Box

X®
OUT

CLEANSING WIPES
FOR ON-THE-GO BLEMISH TREATMENT

From the Makers of Proactiv®

benzoyl peroxide acne treatment
Contents: 10 pre-moistened wipes

PRINCIPAL DISPLAY PANEL - 10 Swab Box
X OUT CLEANSING WIPES FOR ON THE GO BLEMISH TREATMENT 
benzoyl peroxide swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-003
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.75 mg
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
PROPANEDIOL (UNII: 5965N8W85T)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
STEARETH-20 (UNII: L0Q8IK9E08)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)  
ALLANTOIN (UNII: 344S277G0Z)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
PANTHENOL (UNII: WV9CM0O67Z)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
BENTONITE (UNII: A3N5ZCN45C)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11410-003-9110 in 1 BOX12/31/201205/27/2019
11 in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D12/31/201205/27/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Establishment
NameAddressID/FEIBusiness Operations
VEE PAK, LLC874763303manufacture(11410-003)

Revised: 1/2013