PROACTIVPLUS SMOOTHING BHA CLEANSER- salicylic acid liquid

Proactivplus Smoothing BHA Cleanser by

Drug Labeling and Warnings

Proactivplus Smoothing BHA Cleanser by is a Otc medication manufactured, distributed, or labeled by Alchemee, LLC, Vee Pak, LLC dba Voyant Beauty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic Acid 1%

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.

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.
• cover the entire affected area with a thin layer and rinse thoroughlyone 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
• if going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

Water, Cetearyl Alcohol, Glycerin, Cetyl Alcohol, Propanediol, Paraffin, Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 20, Xanthan Gum, Phenoxyethanol, Coco-Glucoside, Glyceryl Oleate, Sodium Hydroxide, Polyacrylate Crosspolymer-6, Ethylhexylglycerin, Citric Acid, Aloe Barbadensis Leaf Juice, t-Butyl Alcohol, Tocopherol, Hydrogenated Palm Glycerides Citrate.

Questions or comments?

1-800-950-4695

SPL UNCLASSIFIED SECTION

Distributed by Alchemee LLC, Hawthorne, NY 10532
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 - 60 mL Carton

proactiv+

Smoothing

BHA Cleanser
acne treatment

1% salicylic acid

6 FL. OZ. (177.4 mL)

INGREDIENTS AND APPEARANCE

PROACTIVPLUS SMOOTHING BHA CLEANSER 
salicylic acid liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11410-216
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCOLIC ACID (UNII: 0WT12SX38S)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PARAFFIN (UNII: I9O0E3H2ZE)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYDROGENATED PALM GLYCERIDES CITRATE (UNII: 23AS6RA25L)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PROPANEDIOL (UNII: 5965N8W85T)
PEG-100 STEARATE (UNII: YD01N1999R)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
COCO-GLUCOSIDE (UNII: ICS790225B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
GLYCERYL OLEATE (UNII: 4PC054V79P)
TOCOPHEROL (UNII: R0ZB2556P8)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11410-216-01	1 in 1 BOX	03/25/2024
1		177.4 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 11410-216-02	1 in 1 BOX	03/25/2024
2		60 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	03/25/2024

Labeler - Alchemee, LLC (080216357)

Establishment
Name	Address	ID/FEI	Business Operations
Vee Pak, LLC dba Voyant Beauty		874763303	manufacture(11410-216)