PROACTIV SKIN CLEARING WATER- salicylic acid gel 
Alchemee, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Proactiv® Skin Clearing Water Gel

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

  • do not use this product more than three times per day.
  • skin irritation and dryness are 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.

Stop use and ask a doctor if

  • irritation becomes severe.

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 uses. If no discomfort occurs, follow the directions stated below.
  • cleanse 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, Butylene Glycol, Niacinamide, Cyclopentasiloxane, Dimethicone, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Cetyl Ethylhexanoate, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Propanediol, Polygonum Cuspidatum Root Extract, Myristyl Alcohol, Tetrasodium EDTA, PCA, Ethylhexylglycerin, Sodium Hyaluronate, Sodium Hydroxide, 1,2-Hexanediol, Caprylyl Glycol, Isohexadecane, Polysorbate 60, Phenoxyethanol, Fragrance, Blue 1

Questions or comments?

Within US 1-800-950-4695

Distributed by The Proactiv Company, LLC.
100 N Sepulveda Blvd., El Segundo, CA 90245

PRINCIPAL DISPLAY PANEL - 90mL Tube Box

proactiv®

SKIN CLEARING WATER GEL

3 FL. OZ. 90mL

salicylic acid acne medication

PRINCIPAL DISPLAY PANEL - 90 mL Tube Box
PROACTIV SKIN CLEARING WATER 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-049
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
Niacinamide (UNII: 25X51I8RD4)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) (UNII: 86FQE96TZ4)  
Carbomer Interpolymer Type A (allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
Cetyl Ethylhexanoate (UNII: 134647WMX4)  
Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) (UNII: 9E4CO0W6C5)  
Silicon Dioxide (UNII: ETJ7Z6XBU4)  
Polygonum Cuspidatum Root (UNII: 7TRV45YZF7)  
Myristyl Alcohol (UNII: V42034O9PU)  
Edetate Sodium (UNII: MP1J8420LU)  
Pidolic Acid (UNII: SZB83O1W42)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Sodium Hydroxide (UNII: 55X04QC32I)  
1,2-hexanediol (UNII: TR046Y3K1G)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Isohexadecane (UNII: 918X1OUF1E)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Fd&c Blue No. 1 (UNII: H3R47K3TBD)  
Propanediol (UNII: 5965N8W85T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-049-741 in 1 BOX10/28/201610/05/2018
190 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:11410-049-771 in 1 CARTON10/26/201801/13/2019
230 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D10/28/201601/13/2019
Labeler - Alchemee, LLC (080216357)
Establishment
NameAddressID/FEIBusiness Operations
KIK Holdco Company Inc243547333manufacture(11410-049)

Revised: 12/2022
 
Alchemee, LLC