PROACTIV SKIN CLEARING WATER- salicylic acid gel

Proactiv Skin Clearing Water by

Drug Labeling and Warnings

Proactiv Skin Clearing Water by is a Otc medication manufactured, distributed, or labeled by The Proactiv Company, LLC, KIK Holdco Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic acid 2%

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 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.

Directions

• Sensitivity Test for a New User: Apply product sparingly to one or two small affected areas during the first 3 uses. 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 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.

Inactive ingredients

Water, Butylene Glycol, Niacinamide, Cyclopentasiloxane, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetyl Ethylhexanoate, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Propanediol, Polygonum Cuspidatum Root Extract, Myristyl Alcohol, Tetrasodium EDTA, PCA, Ethylhexylglycerin, Sodium Hyaluronate, Sodium Hydroxide, 1,2-Hexanediol, Caprylyl Glycol, Isohexadecane, Polysorbate 60, Phenoxyethanol, Fragrance, Blue 1

Questions or comments?

Within US 1-800-950-4695

SPL UNCLASSIFIED SECTION

Distributed by The Proactiv Company, LLC.
100 N Sepulveda Blvd., El Segundo, CA 90245

PRINCIPAL DISPLAY PANEL - 90mL Tube Box

proactiv®

SKIN CLEARING WATER GEL

3 FL. OZ. 90mL

salicylic acid acne medication

INGREDIENTS AND APPEARANCE

PROACTIV SKIN CLEARING WATER 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-049
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.2 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Niacinamide (UNII: 25X51I8RD4)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Dimethicone (UNII: 92RU3N3Y1O)
Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) (UNII: 86FQE96TZ4)
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Cetyl Ethylhexanoate (UNII: 134647WMX4)
Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) (UNII: 9E4CO0W6C5)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Polygonum Cuspidatum Root (UNII: 7TRV45YZF7)
Myristyl Alcohol (UNII: V42034O9PU)
Edetate Sodium (UNII: MP1J8420LU)
Pidolic Acid (UNII: SZB83O1W42)
Ethylhexylglycerin (UNII: 147D247K3P)
Hyaluronate Sodium (UNII: YSE9PPT4TH)
Sodium Hydroxide (UNII: 55X04QC32I)
1,2-hexanediol (UNII: TR046Y3K1G)
Caprylyl Glycol (UNII: 00YIU5438U)
Isohexadecane (UNII: 918X1OUF1E)
Polysorbate 60 (UNII: CAL22UVI4M)
Phenoxyethanol (UNII: HIE492ZZ3T)
Fd&c Blue No. 1 (UNII: H3R47K3TBD)
Propanediol (UNII: 5965N8W85T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-049-74	1 in 1 BOX	10/28/2016
1		90 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11410-049-77	1 in 1 CARTON	10/26/2018
2		30 mL in 1 TUBE; 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	10/28/2016

Labeler - The Proactiv Company, LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
KIK Holdco Company Inc		243547333	manufacture(11410-049)