Proactiv Cleansing Body Bar

PROACTIV PLUS CLEANSING BODY BAR by

Drug Labeling and Warnings

PROACTIV PLUS CLEANSING BODY BAR by is a Otc medication manufactured, distributed, or labeled by THE PROACTIV COMPANY LLC, Bradford Soap Works, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV PLUS CLEANSING BODY BAR- salicylic acid soap 
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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Proactiv Cleansing Body Bar

Drug Facts

Active ingredient

Salicylic acid 1%

Purpose

Acne treatment

Use

for the management of acne

Warnings

For external use only

When using this product

  • do not use this product more than three times a day
  • 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

  • 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 below. 
  • 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 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

sodium cocoyl isethionate, stearic acid, water, sodium isethionate, fragrance, cocamidopropyl hydroxysultaine, sodium chloride, galactoarabinan, disodium EDTA, pentasodium pentetate, titanium dioxide 

Questions or comments?

Within US 1-800-950-4695

Distributed by The Proactiv Company LLC ● 100 N Sepulveda Blvd., El Segundo, CA 90245 ● proactiv.com
Made in the USA of Foreign and Domestic Components ● Proactiv is a trademark of the Proactiv Company Sàrl

PRINCIPAL DISPLAY PANEL - 150 g Bar Carton

proactiv®

CLEANSING
BODY
BAR
                 

Net wt. 5.25 OZ. 150 g
salicylic acid acne treatment

Poractiv Cleansing Body Bar 150g Carton

PRINCIPAL DISPLAY PANEL - 79 g Bar Carton

proactiv®

CLEANSING
BODY
BAR
     

Net wt. 2.7 OZ. 79 g
salicylic acid acne treatment

Proactiv Cleansing Body Bar 79g Carton
PROACTIV PLUS CLEANSING BODY BAR 
salicylic acid soap
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-027
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 mg  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
WATER (UNII: 059QF0KO0R)  
SODIUM ISETHIONATE (UNII: 3R36J71C17)  
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GALACTOARABINAN (UNII: SL4SX1O487)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11410-027-371 in 1 CARTON06/01/201306/30/2019
1141 g in 1 APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D06/01/201306/30/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Establishment
NameAddressID/FEIBusiness Operations
Bradford Soap Works, Inc.001201045manufacture(11410-027)

Revised: 12/2017