PROACTIV ADVANCED DAILY OIL CONTROL- salicylic acid lotion

Proactiv Advanced Daily Oil Control by

Drug Labeling and Warnings

Proactiv Advanced Daily Oil Control 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]

Drug Facts

Active Ingredient

Salicylic Acid 0.5%

Purpose

Acne treatment gel

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 toptical 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, 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

Questions or comments?
Within US 1-800-950-4695

SPL UNCLASSIFIED SECTION

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.

PRINCIPAL DISPLAY PANEL - 22 mL Carton

 
proactiv®                     

ADVANCED
DAILY OIL
CONTROL

0.75 FL. OZ. 22 mL

salicylic acid acne medication           

PRINCIPAL DISPLAY PANEL - 75 mL Carton

proactiv®  

ADVANCED
DAILY
OIL CONTROL

2.5 FL. OZ. 75 mL

salicylic acid acne medication

INGREDIENTS AND APPEARANCE

PROACTIV ADVANCED DAILY OIL CONTROL 
salicylic acid lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-055
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)
Alcohol (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-055-00	1 in 1 BOX	03/01/2012
1		75 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11410-055-05	1 in 1 BOX	03/01/2012
2		22 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	03/01/2012

Labeler - The Proactiv Company, LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-055)