Proactiv+ Skin Purifying Mask

Proactiv plus Skin Purifying Mask by

Drug Labeling and Warnings

Proactiv plus Skin Purifying 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 PLUS SKIN PURIFYING MASK- sulfur 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+ Skin Purifying Mask

Drug Facts

Active ingredient

Sulfur 6%

Purpose

Acne treatment cream

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.
• apply only to areas with acne.

Do not use on

• broken skin
• large areas of the skin

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 and rinse thoroughly 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), kaolin, glycereth-26, linoleic acid, cetearyl alcohol, magnesium aluminum silicate, synthetic wax, zinc oxide, sodium lauroyl sarcosinate, ceteareth-20, linolenic acid, cymbopogon schoenanthus extract, geranium maculatum extract, melaleuca alternifolia (tea tree) leaf oil, tocopherol, tocopheryl acetate, butylene glycol, hydrated silica, ethoxydiglycol, phenoxyethanol, methylisothiazolinone, fragrance (parfum), chromium hydroxide green (CI 77289), titanium dioxide (CI 77891)

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 - 85 g Tube Box

Rodan & Fields
proactiv+

Skin
Purifying
Mask

Net wt. 3 OZ. 85 g
sulfur acne
treatment

PROACTIV PLUS SKIN PURIFYING MASK 
sulfur lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-008
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)
GLYCERETH-26 (UNII: NNE56F2N14)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)
ZINC OXIDE (UNII: SOI2LOH54Z)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
LINOLENIC ACID (UNII: 0RBV727H71)
CYMBOPOGON SCHOENANTHUS TOP (UNII: 9SJI1LW39W)
GERANIUM MACULATUM ROOT (UNII: 93IXI5B6OJ)
TEA TREE OIL (UNII: VIF565UC2G)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
CHROMIUM HYDROXIDE GREEN (UNII: RV8FT8XF5R)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-008-11	1 in 1 BOX	05/23/2019	06/30/2019
1		30 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11410-008-25	1 in 1 BOX	05/23/2019	06/30/2019
2		85 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11410-008-54	1 in 1 BOX	05/23/2019	06/30/2019
3		0.28 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	12/31/2012	06/30/2019

Labeler - THE PROACTIV COMPANY LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-008)

Revised: 3/2016

Document Id: 72fd4d6d-149f-4c81-b677-eb00367ce3a0

34390-5

Set id: fa406f1d-3e3d-4ede-a2f1-489b83f73145

Version: 5

Effective Time: 20160330

 

THE PROACTIV COMPANY LLC