PROACTIV PLUS COMPLEXION PERFECTING HYDRATOR- salicylic acid lotion 
Guthy-Renker 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

  • 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

Inactive ingredients

water (aqua), 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 (parfum)

Questions or comments?

Within US 1-800-950-4695

Dist. by: Guthy-Renker® LLC • PO Box 14383
Palm Desert, CA 92255-4383

PRINCIPAL DISPLAY PANEL - 89 mL Jar Box

Rodan & Fields
proactiv+

Complexion
Perfecting
Hydrator

3 FL. OZ. 89 mL

salicylic acid
acne treatment

Principal Display Panel - 89 mL Jar Box
PROACTIV PLUS COMPLEXION PERFECTING HYDRATOR 
salicylic acid lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11410-010
Route of Administration TOPICAL DEA Schedule     
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)  
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:11410-010-49 1 in 1 BOX
1 89 mL in 1 JAR
2 NDC:11410-010-43 1 in 1 BOX
2 29.57 mL in 1 JAR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333D 03/01/2013
Labeler - Guthy-Renker LLC (608315453)

Revised: 2/2013
Document Id: c93030df-7661-4688-9e2a-1355b6c8893c
Set id: bc7fce80-824a-4aeb-8294-f9850a221106
Version: 1
Effective Time: 20130213
 
Guthy-Renker LLC