PROACTIV CLEAN ACNE CLEARING HYDRATOR- salicylic acid gel

Proactiv Clean Acne Clearing Hydrator by

Drug Labeling and Warnings

Proactiv Clean Acne Clearing Hydrator 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

Salicylic Acid 2%

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.
• avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

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.
• clean 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, Glycerin, Glyceryl Stearate SE, Propanediol, Cetyl Phosphate, Cetyl Alcohol, Stearic Acid, Dicaprylyl Carbonate, Undecane, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Sodium Hydroxide, Pentylene Glycol, Cetearyl Alcohol, Tridecane, Bakuchiol, Caprylyl Glycol, Xanthan Gum, Ethylhexylglycerin, Tocopheryl Acetate, Sodium Hyaluronate, Phenoxyethanol, Tocopherol

Questions or comments?

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 - 3 FL. OZ. (89 mL)

proactiv®    

proactivclean TM

Acne Clearing
Hydrator

3 FL. OZ. (89 mL)

salicylic acid 
acne treatment

INGREDIENTS AND APPEARANCE

PROACTIV CLEAN ACNE CLEARING HYDRATOR 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-458
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPANEDIOL (UNII: 5965N8W85T)
CETYL PHOSPHATE (UNII: VT07D6X67O)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARIC ACID (UNII: 4ELV7Z65AP)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
UNDECANE (UNII: JV0QT00NUE)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
TRIDECANE (UNII: A3LZF0L939)
BAKUCHIOL (UNII: OT12HJU3AR)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
TOCOPHEROL (UNII: R0ZB2556P8)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-458-00	1 in 1 BOX	02/01/2023
1		10 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11410-458-05	30 mL in 1 TUBE; Type 0: Not a Combination Product	02/01/2023
3	NDC: 11410-458-10	1 in 1 BOX	02/01/2023
3		30 mL in 1 TUBE; Type 0: Not a Combination Product
4	NDC: 11410-458-15	1 in 1 BOX	02/01/2023
4		89 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 Drug	M006	02/01/2023

Labeler - Alchemee, LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
kdc/one Chatsworth, Inc.		118542196	manufacture(11410-458)