Proactiv+ Complexion Perfecting Hydrator

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 THE PROACTIV COMPANY LLC, VEE PAK, LLC, KIK Holdco Company Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV PLUS COMPLEXION PERFECTING HYDRATOR- salicylic acid lotion 
THE PROACTIV COMPANY LLC

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.

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Proactiv+ Complexion Perfecting Hydrator

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                 

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

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 - 30 mL

proactiv+

Complexion
Perfecting
Hydrator

 1 FL. OZ. 30 mL

salicylic acid
acne treatment

30_ml_carton_image-USA
30_ml_carton_image_canada

PRINCIPAL DISPLAY PANEL - 89 mL

proactiv+

Complexion
Perfecting
Hydrator

3 FL. OZ.  89 mL

salicylic acid
acne treatment

89_ml_carton_image_USA
89_ml_carton_image_canada
PROACTIV PLUS COMPLEXION PERFECTING HYDRATOR 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 11410-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11410-010-491 in 1 BOX03/01/201306/30/2019
189 mL in 1 JAR; Type 0: Not a Combination Product
2NDC: 11410-010-431 in 1 BOX03/01/201306/30/2019
229.57 mL in 1 JAR; Type 0: Not a Combination Product
3NDC: 11410-010-591 in 1 BOX03/01/201306/30/2019
389 mL in 1 TUBE; Type 0: Not a Combination Product
4NDC: 11410-010-291 in 1 BOX03/01/201306/30/2019
430 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D03/01/201306/30/2019
Labeler - THE PROACTIV COMPANY LLC (080216357)
Establishment
NameAddressID/FEIBusiness Operations
VEE PAK, LLC874763303manufacture(11410-010)
Establishment
NameAddressID/FEIBusiness Operations
KIK Holdco Company Inc243547333manufacture(11410-010)

Revised: 11/2017
 
THE PROACTIV COMPANY LLC