PROACTIV EXTRA STRENGTH FORMULA TONER- salicylic acid liquid

Proactiv Extra Strength Formula Toner by

Drug Labeling and Warnings

Proactiv Extra Strength Formula Toner by is a Otc medication manufactured, distributed, or labeled by THE PROACTIV COMPANY LLC, Topiderm Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

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.

Sunburn Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn.  Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

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.
• cleanse the skin thoroughly before applying this product.
• cover the entire affected area with a thin layer one or 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, alcohol denat, hamamelis virginiana (witch hazel) extract, glycolic acid, ammonium hydroxide, polysorbate 20, sodium benzoate, imidazolidinyl urea, disodium EDTA

Questions or comments?
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PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

proactiv®

EXTRA STRENGTH
FORMULA

toner

2

salicylic acid acne medication

4 FL. OZ. 120 mL

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 Proactiv Company Sàrl.

INGREDIENTS AND APPEARANCE

PROACTIV EXTRA STRENGTH FORMULA TONER 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-054
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alcohol (UNII: 3K9958V90M)
Hamamelis Virginiana Root Bark/stem Bark (UNII: T7S323PKJS)
Glycolic Acid (UNII: 0WT12SX38S)
Ammonia (UNII: 5138Q19F1X)
Polysorbate 20 (UNII: 7T1F30V5YH)
Sodium Benzoate (UNII: OJ245FE5EU)
Imidurea (UNII: M629807ATL)
Edetate Disodium (UNII: 7FLD91C86K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-054-00	1 in 1 CARTON	01/01/2003
1		120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	01/01/2003

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm Inc.		049121643	manufacture(11410-054)