Proactiv® Solution Advanced Daily Oil Control

Proactiv Solution Advanced Daily Oil Control by

Drug Labeling and Warnings

Proactiv Solution Advanced Daily Oil Control by is a Otc medication manufactured, distributed, or labeled by Guthy-Renker LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV SOLUTION ADVANCED DAILY OIL CONTROL- 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® Solution Advanced Daily Oil Control

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

• using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
• avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.
• avoid unnecessary sun exposure and use a sunscreen.

Stop use and ask a doctor if skin irritation occurs.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Apply daily or as needed onto clean skin.
• Use fingertips to gently apply a thin layer to the entire face.
• Allow to dry completely.
• For best results, use after Repairing Treatment.

Inactive Ingredients

water (aqua), alcohol denat., butylene glycol, cyclopentasiloxane, glyceryl stearate, PEG-100 stearate, nylon-12, PVM/MA decadiene crosspolymer, aluminum starch octenylsuccinate, cyclohexasiloxane, decylene glycol, 10-hydroxydecanoic acid, sebacic acid, 1,10-decanediol, sarcosine, xanthan gum, hexylene glycol, sodium hydroxide, disodium EDTA, caprylyl glycol, pentylene glycol, phenoxyethanol, fragrance (parfum).

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

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

Rodan & Fields
proactiv®
SOLUTION

NEW
FORMULA!

ADVANCED
DAILY OIL
CONTROL

non-comedogenic
helps to eliminate shine

salicylic acid acne treatment

1 FL. OZ. 30 mL

PROACTIV SOLUTION ADVANCED DAILY OIL CONTROL 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-611
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 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
NYLON-12 (UNII: 446U8J075B)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
DECYLENE GLYCOL (UNII: S57M60MI88)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
10-HYDROXYDECANOIC ACID (UNII: NP03XO416B)
SEBACIC ACID (UNII: 97AN39ICTC)
1,10-DECANEDIOL (UNII: 5I577UDK52)
SARCOSINE (UNII: Z711V88R5F)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-611-29	1 in 1 BOX	03/01/2012	12/31/2019
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11410-611-17	1 in 1 BOX	03/01/2012	12/31/2019
2		50 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11410-611-21	30 mL in 1 TUBE; Type 0: Not a Combination Product	03/01/2012	12/31/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	03/01/2012	12/31/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Registrant - THE PROACTIV COMPANY LLC (080216357)

Revised: 8/2012

Document Id: 0e5a141f-0fc3-4ef1-bab3-76e62f13ec9d

34390-5

Set id: 889613d2-6645-4790-912c-ff0d6e4758be

Version: 3

Effective Time: 20120814

 

THE PROACTIV COMPANY LLC