Proactiv® Solution Refining Mask

Proactiv Solution Refining Mask by

Drug Labeling and Warnings

Proactiv Solution Refining Mask by is a Otc medication manufactured, distributed, or labeled by THE PROACTIV COMPANY LLC, VEE PAK, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROACTIV SOLUTION REFINING MASK- sulfur cream 
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 Refining Mask

Recommended purpose or use

Helps treat acne pimples.

Directions for use

Cleanse skin thoroughly before applying the product. Apply product to affected areas for ten minutes two to three times per week or as directed by a doctor. Rinse off with water.

Additional use

Cleanse skin thoroughly before applying the product. Apply a small dab directly on a pimple for overnight spot treatment or as directed by a doctor.

Warnings

For external use only. Using other topical acne products at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one product should be used unless directed by a doctor. Avoid contact with eyes; if contact occurs, rinse thoroughly with water.

Discontinue use if excessive skin irritation develops or increases. If irritation persists, consult a doctor.

Keep out of reach of children.

Medicinal ingredient

sulfur 6%

Non medicinal ingredients

water (aqua/eau), kaolin, glycereth-26, linoleic acid, cetearyl alcohol, magnesium aluminum silicate, ceteareth-20, sodium lauroyl sarcosinate, linolenic acid, cymbopogon schoenanthus extract, geranium maculatum extract, melaleuca alternifolia (tea tree) leaf oil, tocopherol, tocopheryl acetate, butylene glycol, hydrated silica, ethoxydiglycol, fragrance (parfum), ethylparaben, methylparaben, titanium dioxide (CI 77891), zinc oxide (CI 77947)

PRINCIPAL DISPLAY PANEL - 70 g Tube Carton

Rodan & Fields
proactiv®
SOLUTION

REFINING
MASK

sulfur acne treatment

NPN 02239397
70 g 2.5 OZ.

PROACTIV SOLUTION REFINING MASK 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Sulfur (UNII: 70FD1KFU70) (Sulfur - UNII:70FD1KFU70)	Sulfur	6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
KAOLIN (UNII: 24H4NWX5CO)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
ZINC OXIDE (UNII: SOI2LOH54Z)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
LINOLENIC ACID (UNII: 0RBV727H71)
TEA TREE OIL (UNII: VIF565UC2G)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
ETHYLPARABEN (UNII: 14255EXE39)
METHYLPARABEN (UNII: A2I8C7HI9T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-021-29	1 in 1 BOX	08/01/2013	06/30/2019
1		28 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11410-021-28	1 in 1 BOX	08/01/2013	06/30/2019
2		70 g 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	08/01/2013	06/30/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-021)

Revised: 4/2013

Document Id: a4db7694-c16b-4be3-a883-69f2bdd6c289

34390-5

Set id: a2f55895-130f-4906-87f3-530382f937c8

Version: 2

Effective Time: 20130411

 

THE PROACTIV COMPANY LLC