PROACTIV PLUS COMPLEXION PERFECTING HYDRATOR- salicylic acid lotion

Proactiv Plus Complexion Perfecting Hydrator by

Drug Labeling and Warnings

Proactiv Plus Complexion Perfecting Hydrator by is a Otc medication manufactured, distributed, or labeled by Alchemee, LLC, VEE PAK, LLC, Apex International Mfg LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic acid 0.5%

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 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 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, cetearyl alcohol, dimethicone, sodium polyacrylate, scutellaria baicalensis root extract, sophora angustifolia root extract, morus alba root extract, glycyrrhiza glabra (licorice) root extract, arctostaphylos uva ursi leaf extract, kojic acid, zinc gluconate, alpha-glucan oligosaccharide, sodium hyaluronate, bisabolol, allantoin, squalane, safflower oil/palm oil aminopropanediol esters, C12-15 alkyl lactate, caprylic/capric triglyceride, caprylyl glycol, ethylhexylglycerin, glycerin, ethylhexyl palmitate, hydrogenated polydecene, hydroxypropyl cyclodextrin, PPG-5 laureth-5, polyquaternium-11, ceteareth-20, aluminum starch octenylsuccinate, polysorbate 60, hexylene glycol, PPG-2 myristyl ether propionate, sodium hydroxide, disodium EDTA, phenoxyethanol, fragrance

Questions or comments?

Within US 1-800-950-4695                 

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 30 mL

proactiv+

Complexion
Perfecting
Hydrator

 1 FL. OZ. 30 mL

salicylic acid
acne treatment

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

Proactiv+ is a trademark of The Proactiv Company Sàrl.

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245
proactiv.com  Manufactured in Canada.

Proactiv+ is a trademark of The Proactiv Company Sàrl.

PRINCIPAL DISPLAY PANEL - 89 mL

proactiv+

Complexion
Perfecting
Hydrator

3 FL. OZ.  89 mL

salicylic acid
acne treatment

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.

Distributed by The Proactiv Company LLC
100 N Sepulveda Blvd., El Segundo, CA 90245
proactiv.com  Manufactured in Canada.

Proactiv is a trademark of The Proactiv Company Sàrl.

INGREDIENTS AND APPEARANCE

PROACTIV PLUS COMPLEXION PERFECTING HYDRATOR 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
MORUS ALBA ROOT (UNII: CST1G9BZGD)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
ARCTOSTAPHYLOS UVA-URSI LEAF (UNII: 3M5V3D1X36)
KOJIC ACID (UNII: 6K23F1TT52)
ZINC GLUCONATE (UNII: U6WSN5SQ1Z)
.ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
Levomenol (UNII: 24WE03BX2T)
ALLANTOIN (UNII: 344S277G0Z)
SQUALANE (UNII: GW89575KF9)
Safflower Oil (UNII: 65UEH262IS)
C12-15 Alkyl Lactate (UNII: GC844VRD7E)
Medium-chain Triglycerides (UNII: C9H2L21V7U)
Caprylyl Glycol (UNII: 00YIU5438U)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
Ethylhexyl Palmitate (UNII: 2865993309)
Hydrogenated Polydecene (550 Mw) (UNII: U333RI6EB7)
Polyquaternium-11 (1000000 Mw) (UNII: 0B44BS5IJS)
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Polysorbate 60 (UNII: CAL22UVI4M)
Hexylene Glycol (UNII: KEH0A3F75J)
Ppg-2 Myristyl Ether Propionate (UNII: 88R97D8U8A)
Sodium Hydroxide (UNII: 55X04QC32I)
Edetate Disodium (UNII: 7FLD91C86K)
Phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-023-05	1 in 1 BOX	03/01/2013
1		89 mL in 1 JAR; Type 0: Not a Combination Product
2	NDC: 11410-023-10	1 in 1 BOX	03/01/2013
2		89 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11410-023-00	1 in 1 BOX	03/01/2013
3		30 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 11410-023-15	89 mL in 1 TUBE; Type 0: Not a Combination Product	03/03/2013
5	NDC: 11410-023-20	1 in 1 CARTON	10/01/2019
5		10 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	03/01/2013

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-023)

Establishment
Name	Address	ID/FEI	Business Operations
KIK Holdco Company Inc		243547333	manufacture(11410-023)