PROACTIV GENTLE FORMULA CLARIFYING DAY- salicylic acid lotion 
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.

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proactiv® Gentle Formula Clarifying Day Lotion

Drug Facts

Active Ingredient

Salicylic Acid 2.0%

Purpose

Acne Treatment

Use

For the management of acne

Warnings

For external use only

When using this product

  • 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 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.
  • 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, Cyclopentasiloxane, Dimethicone, PPG-12/SMDI Copolymer, Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer, Squalane, Glyceryl Stearate, PEG-100 Stearate, Hexylene Glycol, Cetearyl Alcohol, Linoleamidopropyl PG-Dimonium Chloride Phosphate, Rosmarinus Officinalis (Rosemary) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, Melaleuca Alternifolia (Tea Tree) Flower Leaf/Stem Extract, Retinyl Palmitate, Glycerin, Polysorbate 60, Propylene Glycol, Sodium Hydroxide, Phenoxyethanol, Chlorphenesin, Methylparaben, Benzoic Acid, Fragrance

PRINCIPAL DISPLAY PANEL - 60 mL Carton

proactiv®

Gentle Formula

clarifying
day lotion

A.M. 3

salicylic acid acne medication

2 FL. OZ. 60 mL

Proactiv Gentle Formula Clarifying Day Lotion Carton
PROACTIV GENTLE FORMULA CLARIFYING DAY 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11410-052
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
Squalane (UNII: GW89575KF9)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Peg-100 Stearate (UNII: YD01N1999R)  
Hexylene Glycol (UNII: KEH0A3F75J)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Linoleamidopropyl Pg-dimonium Chloride Phosphate (UNII: 5Q87K461JO)  
Rosemary (UNII: IJ67X351P9)  
Matricaria Recutita (UNII: G0R4UBI2ZZ)  
Vitamin A Palmitate (UNII: 1D1K0N0VVC)  
Glycerin (UNII: PDC6A3C0OX)  
Polysorbate 60 (UNII: CAL22UVI4M)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Sodium Hydroxide (UNII: 55X04QC32I)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Chlorphenesin (UNII: I670DAL4SZ)  
Methylparaben (UNII: A2I8C7HI9T)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
Ppg-12/smdi Copolymer (UNII: 1BK9DDD24E)  
Melaleuca Alternifolia Flowering Top (UNII: 5AZ4S6N66F)  
Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) (UNII: 86FQE96TZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11410-052-001 in 1 BOX12/01/200308/02/2021
160 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D12/01/200308/02/2021
Labeler - Alchemee, LLC (080216357)
Establishment
NameAddressID/FEIBusiness Operations
VEE PAK, LLC874763303manufacture(11410-052)

Revised: 12/2022
 
Alchemee, LLC