Paula's Choice Anti-Redness Exfoliating Solution

Paulas Choice by

Drug Labeling and Warnings

Paulas Choice by is a Otc medication manufactured, distributed, or labeled by Prime Enterprises, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PAULAS CHOICE ANTI-REDNESS- salicylic acid liquid 
Prime Enterprises, Inc.

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Paula's Choice Anti-Redness Exfoliating Solution

Active Ingredients

Salicylic Acid 2.0%

Purpose

Acne treatment

Use

  • For the treatment of acne
  • Penetrates pores to eliminate most acne blemishes, blackheads and whiteheads
  • Helps prevent new acne blemishes, blackheads and whiteheads

Warnings

For external use only.

When using this product skin irritation and dryness is more liketly 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.

Do not use

  • on broken skin
  • on large areas of the body

Stop use and ask a doctor ifskin irritation occurs or gets worse.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • After cleansing, 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(Aqua), Methylpropanediol, Butylene Glycol, Polysorbate 20, Camellia Oleifera (Green Tea) Leaf Extract, Sodium Hydroxide, Tetrasodium EDTA

Questions or comments?

Call 1.800.831.4088 (U.S. and Canada)

Mon-Fri 6AM-6PM PT | Sat-Sun 8AM-4:30OM PT

Principal Display LabelPrincipal Display Back

PAULAS CHOICE  ANTI-REDNESS
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58443-0652
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20.6 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
EDETATE SODIUM (UNII: MP1J8420LU)  
METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
Product Characteristics
Colorwhite (Colorless) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58443-0652-230 mL in 1 BOTTLE; Type 0: Not a Combination Product04/25/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00604/25/2023
Labeler - Prime Enterprises, Inc. (101946028)
Registrant - Prime Enterprises, Inc. (101946028)
Establishment
NameAddressID/FEIBusiness Operations
Prime Enterprises, Inc.101946028pack(58443-0652) , manufacture(58443-0652) , analysis(58443-0652) , label(58443-0652)

Revised: 5/2024
Document Id: 178ff233-209b-58ca-e063-6294a90a6872
Set id: 178fedaf-e201-4685-e063-6294a90a1d07
Version: 1
Effective Time: 20240503