OTC Medication Information: Proactiv Clean Acne Clearing Hydrator

PROACTIV CLEAN ACNE CLEARING HYDRATOR- salicylic acid gel
Alchemee, LLC

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

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®

proactiv clean TM
Acne Clearing
Hydrator

3 FL. OZ. (89 mL)

salicylic acid
acne treatment

unit carton image
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 2 mg in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
PROPANEDIOL
CETYL PHOSPHATE
CETYL ALCOHOL
STEARIC ACID
DICAPRYLYL CARBONATE
UNDECANE
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
PENTYLENE GLYCOL
CETOSTEARYL ALCOHOL
TRIDECANE
BAKUCHIOL
GLYCERYL MONOSTEARATE
CAPRYLYL GLYCOL
XANTHAN GUM
ETHYLHEXYLGLYCERIN
.ALPHA.-TOCOPHEROL ACETATE
HYALURONATE SODIUM
TOCOPHEROL
SODIUM HYDROXIDE
PHENOXYETHANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11410-458-00 1 TUBE in 1 BOX contains a TUBE
1 10 mL in 1 TUBE This package is contained within the BOX (11410-458-00)
2 NDC:11410-458-05 30 mL in 1 TUBE None
3 NDC:11410-458-10 1 TUBE in 1 BOX contains a TUBE
3 30 mL in 1 TUBE This package is contained within the BOX (11410-458-10)
4 NDC:11410-458-15 1 TUBE in 1 BOX contains a TUBE
4 89 mL in 1 TUBE This package is contained within the BOX (11410-458-15)
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 Operations
kdc/one Chatsworth, Inc. 118542196 manufacture (11410-458)

Revised: 11/2023 Alchemee, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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