Your browser does not support JavaScript! PROACTIV PLUS COMPLEXION PERFECTING HYDRATOR (SALICYLIC ACID) LOTION [GUTHY-RENKER LLC]
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PROACTIV PLUS COMPLEXION PERFECTING HYDRATOR (salicylic acid) lotion
[Guthy-Renker LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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

  • 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 (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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:11410-010
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BUTYLENE GLYCOL 
CETOSTEARYL ALCOHOL 
DIMETHICONE 
SODIUM POLYACRYLATE (8000 MW) 
SCUTELLARIA BAICALENSIS ROOT 
SOPHORA FLAVESCENS ROOT 
MORUS ALBA ROOT 
GLYCYRRHIZA GLABRA 
ARCTOSTAPHYLOS UVA-URSI LEAF 
KOJIC ACID 
ZINC GLUCONATE 
.ALPHA.-GLUCAN OLIGOSACCHARIDE 
HYALURONATE SODIUM 
LEVOMENOL 
ALLANTOIN 
SQUALANE 
C12-15 ALKYL LACTATE 
MEDIUM-CHAIN TRIGLYCERIDES 
CAPRYLYL GLYCOL 
ETHYLHEXYLGLYCERIN 
GLYCERIN 
ETHYLHEXYL PALMITATE 
HYDROGENATED POLYDECENE (550 MW) 
POLYQUATERNIUM-11 (1000000 MW) 
POLYOXYL 20 CETOSTEARYL ETHER 
ALUMINUM STARCH OCTENYLSUCCINATE 
POLYSORBATE 60 
HEXYLENE GLYCOL 
PPG-2 MYRISTYL ETHER PROPIONATE 
SODIUM HYDROXIDE 
EDETATE DISODIUM 
PHENOXYETHANOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-010-491 in 1 BOX
189 mL in 1 JAR
2NDC:11410-010-431 in 1 BOX
229.57 mL in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D03/01/2013
Labeler - Guthy-Renker LLC (608315453)

Revised: 2/2013
 
Guthy-Renker LLC

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