PROACTIV CLEAN MINERAL ACNE CLEANSER- sulfur cream

Proactiv Clean Mineral Acne Cleanser by

Drug Labeling and Warnings

Proactiv Clean Mineral Acne Cleanser by is a Otc medication manufactured, distributed, or labeled by Alchemee, LLC, kdc/one Chatsworth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Sulfur 3%

Purpose

Acne treatment

Use

for the management of acne

Warnings

For external use only

When using this product

• skin irritation and dryness is 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.
• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Do not useon

• broken skin
• large areas of the skin.

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, follows the directions stated below.
• 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, sodium cocoyl isethionate, coco-glucoside, acrylates copolymer, coconut acid, coconut alcohol, glycereth-18 ethylhexanoate, glycereth-18, behenyl alcohol, titanium dioxide (CI 77891), phenoxyethanol, sodium isethionate, sodium hydroxide, arachidyl alcohol, stearyl alcohol, xanthan gum, ethylhexylglycerin, glycerin, tetrasodium glutamate diacetate, chamomilla recumta (matricaria) flower extract

Questions or comments?

Within US 1-800-950-4695

SPL UNCLASSIFIED SECTION

Distributed by Alchemee LLC. 
Santa Monica, CA 90401 
Questions or comments? 
1-800-950-4695 proactiv.com 
Made in the USA of foreign and domestic components. 
Proactiv is a trademark of Taro Pharmaceuticals U.S.A., Inc.

PRINCIPAL DISPLAY PANEL - 6 FL. OZ. (177.4 mL)

proactivclean TM                        

Mineral
Acne Cleanser

sulfur acne medication

Both treats and helps
prevent breakouts
                

INGREDIENTS AND APPEARANCE

PROACTIV CLEAN MINERAL ACNE CLEANSER 
sulfur cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-457
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
COCO GLUCOSIDE (UNII: ICS790225B)
COCONUT ACID (UNII: 40U37V505D)
COCONUT ALCOHOL (UNII: 13F4MW8Y9K)
GLYCERETH-18 ETHYLHEXANOATE (UNII: IWS58C6V2Y)
GLYCERETH-18 (UNII: SA5E43C17C)
DOCOSANOL (UNII: 9G1OE216XY)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM ISETHIONATE (UNII: 3R36J71C17)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-457-05	1 in 1 BOX	08/15/2022
1		60 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11410-457-10	1 in 1 BOX	08/15/2022
2		177.4 mL in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 11410-457-00	1 in 1 BOX	12/01/2022
3		10 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 11410-457-15	60 mL in 1 TUBE; Type 0: Not a Combination Product	01/24/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	08/15/2022

Labeler - Alchemee, LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
kdc/one Chatsworth, Inc.		118542196	manufacture(11410-457)