Proactive Solution Cleaning Bar: Package Insert and Label Information

PROACTIVE SOLUTION CLEANING BAR- salicylic acid soap
Bradford Soap Works, Inc.

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.

Drug Facts Active 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.

proactiv Body Bar
(click image for full-size original)

PROACTIVE SOLUTION CLEANING BAR
salicylic acid soap
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11118-1209
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 1 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
STEARIC ACID
SODIUM CHLORIDE
TITANIUM DIOXIDE
EDETATE DISODIUM
PENTASODIUM PENTETATE
SODIUM COCOYL ISETHIONATE
SODIUM ISETHIONATE
COCAMIDOPROPYL BETAINE
LOW DENSITY POLYETHYLENE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11118-1209-1 150 g in 1 BOX None
2 NDC:11118-1209-2 79 g in 1 BOX None
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 Operations
Bradford Soap Works, Inc. 001201045 manufacture (11118-1209), label (11118-1209)

Revised: 11/2019 Bradford Soap Works, Inc.

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