PROACTIVE SOLUTION CLEANING BAR- salicylic acid soap

Proactive Solution Cleaning Bar by

Drug Labeling and Warnings

Proactive Solution Cleaning Bar by is a Otc medication manufactured, distributed, or labeled by Bradford Soap Works, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug FactsActive Ingredient

Salicylic Acid 1%

Purpose

Acne Treatment

Use

for the management of acne

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.

• 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 daily or every other day.

Keep out of reach of children

Keep out of reach of children.

If swallowed get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if

• irritation becomes severe.

Warnings

For external use only

Inactive ingredients

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

When using this product

• do not use this prouct 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.

Questions or comments?

Within US 1-800-950-4695

Proactiv Cleansing Body Bar

		7   35786 02037   8
Drug Facts Active ingredient………Purpose Salicylic acid 1%...Acne Treatment Use for management of acne Warnings For external use only When using this product do not use this product more than three times per 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.	Drug Facts (continued) 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. 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.	proactiv® CLEANSING BODY BAR Net wt. 2.7 OZ.  79 g Salicylic acid acne treatment	This soap-free cleansing bar contains acne-fighting salicylic acid to help clear pores as well as treat and help prevent new acne blemishes on the face and body. Sulfate-free dermatologist tested non-comedogenic KEY INGREDIENTS: Salicylic Acid – an acne medicine that penetrates the follicle and encourages the shedding of dead skin cells, helping keep the pores clear of cellular debris. Cleans up acne blemishes and helps prevent new ones from forming. Cleansing Agent – mild, high-foaming cleansing ingredient derived from coconut oil, making proactive Cleansing Body Bar soap-free and surfactant-free. Distributed by The Proactiv Company LLC 100 N Sepulveda Blvd., El Segundo, CA 90245 proactive.com Made in the USA of Foreign and Domestic Components Proactiv is a trademark of the The Proactive Company SanL                  PA01113
		TIPS Wet hands and work bar until it lathers. Apply to dampened skin, gently massaging in an upward circular motion. Rinse thoroughly with warm water and pat dry with a clean towel. Can be used twice daily. If bothersome dryness or peeling occurs, reduce application use to once a day. Can be used all over the face and body or on targeted areas. If using during the day, follow with a sunscreen.

INGREDIENTS AND APPEARANCE

PROACTIVE SOLUTION CLEANING BAR 
salicylic acid soap

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11118-1209
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PENTASODIUM PENTETATE (UNII: 961TOZ5L7T)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
SODIUM ISETHIONATE (UNII: 3R36J71C17)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
LOW DENSITY POLYETHYLENE (UNII: J245LN42AI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11118-1209-1	150 g in 1 BOX; Type 0: Not a Combination Product	09/01/2010
2	NDC: 11118-1209-2	79 g in 1 BOX; Type 0: Not a Combination Product	03/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	09/01/2010

Labeler - Bradford Soap Works, Inc. (001201045)

Registrant - Bradford Soap Works, Inc. (001201045)

Establishment
Name	Address	ID/FEI	Business Operations
Bradford Soap Works, Inc.		001201045	manufacture(11118-1209) , label(11118-1209)