PROACTIV REDNESS CORRECTING TREATMENT- salicylic acid cream

Proactiv Redness Correcting Treatment by

Drug Labeling and Warnings

Proactiv Redness Correcting Treatment by is a Otc medication manufactured, distributed, or labeled by Alchemee, LLC, Apex International Mfg LLC, VEE PAK, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Salicylic acid 1.5%

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 unnecessary sun exposure and use a sunscreen
• 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.

Other Information

Store at 20 - 25°C (68 - 77°F)

Inactive ingredients

Water, Coco-Caprylate, Caprylic/Capric Triglyceride, C9-12 Alkane, Glycerin, Ethoxydiglycol, Titanium Dioxide (CI 77891), Octyldodecyl Oleate, Stearalkonium Hectorite, Magnesium Aluminum Silicate (Argilla), Polyglyceryl-6 Polyricinoleate, Xanthan Gum, Polyglyceryl-3 Diisostearate, Octyldodecyl Stearoyl Stearate, Magnesium Chloride, Phenoxyethanol, Coco-Caprylate/Caprate, Isopropyl Myristate, Chromium Oxide Greens (CI 77288), Polyhydroxystearic Acid, Octyldodecanol, Bisabolol, Ethylhexylglycerin, Sodium Hydroxide, Trihydroxystearin, Stearoyl Glutamic Acid, Propylene Carbonate, Triethoxycaprylylsilane, Tocopherol, Sodium Benzoate, Centella Asiatica Extract.

Questions or comments?

1-800-950-4695                 

Distributed by Alchemee LLC Santa Monica, CA 90401 Made in the USA of Foreign and Domestic Components Questions? 1-800-950-4695 proactiv.com Proactiv is a registered trademark of Taro Pharmaceuticals U.S.A., Inc.

PRINCIPAL DISPLAY PANEL - 89 mL

proactiv

Redness

Correcting

Treatment

acne treatment

1.5% salicylic acid

+ centella asiatica

0.33 OZ. (9.45 g)

INGREDIENTS AND APPEARANCE

PROACTIV REDNESS CORRECTING TREATMENT 
salicylic acid cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-219
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
BISABOLOL (UNII: 24WE03BX2T)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
C9-12 ALKANE (UNII: 7J5R5W72QM)
GLYCERIN (UNII: PDC6A3C0OX)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
WATER (UNII: 059QF0KO0R)
ETHOXYDIGLYCOL (UNII: A1A1I8X02B)
CAPRYLIC/CAPRIC TRIGLYCERIDE (UNII: C9H2L21V7U)
OCTYLDODECYL STEAROYL STEARATE (UNII: 3D47Q6D93C)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEAROYL GLUTAMIC ACID (UNII: 4R4O71786G)
CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)
XANTHAN GUM (UNII: TTV12P4NEE)
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
CHROMIUM OXIDE GREENS (UNII: X5Z09SU859)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
OCTYLDODECANOL (UNII: 461N1O614Y)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
TOCOPHEROL (UNII: R0ZB2556P8)
COCO-CAPRYLATE (UNII: 4828G836N6)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-219-01	1 in 1 BOX	10/31/2024
1		9.45 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	10/31/2024

Labeler - Alchemee, LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
Apex International Mfg LLC		079110793	manufacture(11410-219)

Establishment
Name	Address	ID/FEI	Business Operations
VEE PAK, LLC		874763303	manufacture(11410-219)