Kleer-Plex Advanced Acne Care System

Manufacturer
Bio-Medical & Pharmaceutical Manufacturing Corporation
Effective date
2014-11-03
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 22:40:43

Label at a glance#

ProductKleer-Plex Advanced Acne Care System
Active ingredientSALICYLIC ACID
Label structure13 sections

Indications and uses

For the management of acne. Clears up most acne pimples, blackheads, and whiteheads and allows skin to heal. Penetrates pores to eliminate most acne blemishes. Helps prevent new acne pimples.

Dosage and administration

Acne Treatment Wash At least once each day, dispense a small amount of cleanser onto an exfoliating pad or cloth. Add a small amount of water and work into a lather on the face using small circular motions avoiding the eyes. Repeat after perspiration or makeup use. If dryness occurs, reduce frequency to once each day. Acne Treatment Gel Each night, dispense a small amount of gel onto the fingertips. Spread gel spa...

Label contents#

Full prescribing information#

THIS SYSTEM CONTAINS:

SPL UNCLASSIFIED SECTION

(1) Foaming Acne Clarifier

       NDC 37945-870-40

(1) Pore Purifier & Toner

(1) Penetrating Acne Gel

       NDC 37945-874-11

(1) Targeted Acne Pen

       NDC 37945-894-05

DRUG FACTS

SPL UNCLASSIFIED SECTION

Acne Treatment Wash and Acne Treatment Gel

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid, 2%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • For the management of acne.
  • Clears up most acne pimples, blackheads, and whiteheads and allows skin to heal.
  • Penetrates pores to eliminate most acne blemishes.
  • Helps prevent new acne pimples.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Directions

DOSAGE & ADMINISTRATION SECTION

Acne Treatment Wash

  • At least once each day, dispense a small amount of cleanser onto an exfoliating pad or cloth.
  • Add a small amount of water and work into a lather on the face using small circular motions avoiding the eyes.
  • Repeat after perspiration or makeup use.
  • If dryness occurs, reduce frequency to once each day.

Acne Treatment Gel

  • Each night, dispense a small amount of gel onto the fingertips.
  • Spread gel sparingly on the face and other affected areas using small circular motions avoiding the eyes.
  • Repeat after perspiration or makeup use.
  • If dryness occurs, reduce frequency to once each day.

Sensitivity Test for a New User - Acne Treatment Gel

USER SAFETY WARNINGS SECTION

  • Apply product sparingly to one or two small affected areas during the first 3 days.
  • If no discomfort occurs, follow the directions stated above.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Acne Treatment Wash

Purified Water, Ammonium Lauryl Sulfate, Lauramidopropyl Betaine, Propylene Glycol, Hydroxypropyl Bis-Hydroxyethyldimonium Chloride, Triethanolamine, Hydroxypropylmethylcellulose, Magnesium Sulfate, 3-iodo-2-propynylbutylcarbamate, Diazolidinyl Urea, Peppermint Oil, Methylparaben, Propylparaben.

Acne Treatment Gel

Purified Water, Alcohol, Glycerin, Xanthan Gum, Polysorbate 20, Peppermint Oil, (.Alpha.-Tocopherol Acetate), Wheat Germ Oil, Glycolic Acid, Tert-Butyl Alcohol, Brucine Sulfate.

Questions or Comments

OTC - QUESTIONS SECTION

281-835-8051

M-F 8 AM to 5 PM

Kleer-Plex Advanced Acne SystemPrincipal Display PanelNDC# 37945-876-91

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

KleerPlexFront.jpgFrontFront KleerPlexBack.jpgBackBack

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1592891{1 (30 ML) (salicylic acid 0.02 MG/MG Topical Gel [Kleer Plex]) / 1 (118 ML) (salicylic acid 20 MG/ML Medicated Liquid Soap [Kleer Plex]) } Pack [Kleer Plex Acne Care]BPCK4
1592888{1 (30 ML) (salicylic acid 0.02 MG/MG Topical Gel) / 1 (118 ML) (salicylic acid 20 MG/ML Medicated Liquid Soap) } PackGPCK4
1591999Kleer Plex 2 % Topical GelPSN4
1592891Kleer Plex Acne Care KitPSN4
1591995Kleer-Plex 2 % Medicated Liquid SoapPSN4
562600salicylic acid 2 % Medicated Liquid SoapPSN4
1592888salicylic acid 2 % Medicated Liquid Soap (4 OZ) / salicylic acid 2 % Topical Gel (1 OZ) PackPSN4
346298salicylic acid 2 % Topical GelPSN4
1591999salicylic acid 0.02 MG/MG Topical Gel [Kleer Plex]SBD4
1591995salicylic acid 20 MG/ML Medicated Liquid Soap [Kleer Plex]SBD4
346298salicylic acid 0.02 MG/MG Topical GelSCD4
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD4
1592891{ 1 (15 ML) (salicylic acid 2 % Topical Gel [Kleer Plex]) / 1 (30 ML) (salicylic acid 2 % Topical Gel [Kleer Plex]) / 1 (118 ML) (salicylic acid 2 % Medicated Liquid Soap [Kleer Plex]) } Pack [Kleer Plex Acne Care Kit]SY4
1591999Kleer Plex 0.02 MG/MG Topical GelSY4
1591995Kleer Plex 2 % Medicated Liquid SoapSY4
1591999Kleer Plex 2 % Topical GelSY4
1591995Kleer Plex 20 MG/ML Medicated Liquid SoapSY4
1592891Kleer Plex Acne Care KitSY4
562600salicylic acid 2 % Facial Cleanser TonerSY4
562600salicylic acid 2 % Facial ScrubSY4
562600salicylic acid 2 % Medicated Liquid SoapSY4
346298salicylic acid 2 % Topical GelSY4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37945-876-912020-01-31C16284748780-19d75b9d0-0d87-f424-e053-dadaa90a57ceKleer-Plex Advanced Acne Care System

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37945-870-40Kleer-Plex Advanced Acne Care System1 in 1 BOXLIQUID20 mg in 1mL4
37945-870-40Kleer-Plex Advanced Acne Care System118 mL in 1 BOTTLE, PUMPLIQUID118 mL20 mg in 1mL4
37945-874-11Kleer-Plex Advanced Acne Care System30 mL in 1 BOTTLEGEL30 mL20 mg in 1mL4
37945-874-11Kleer-Plex Advanced Acne Care System1 in 1 BOXGEL20 mg in 1mL4
37945-876-91Kleer-Plex Advanced Acne Care System1 in 1 KITKIT14
37945-894-05Kleer-Plex Advanced Acne Care System15 mL in 1 APPLICATORGEL15 mL20 mg in 1mL4
37945-894-05Kleer-Plex Advanced Acne Care System1 in 1 BOXGEL20 mg in 1mL4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37945-870KLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4Legacy NDC20141103_79f8fc90-2447-4224-ac79-1645d1c82d4f.zip
37945-874KLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4Legacy NDC20141103_79f8fc90-2447-4224-ac79-1645d1c82d4f.zip
37945-876KLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4Legacy NDC, 7 package rows20141103_79f8fc90-2447-4224-ac79-1645d1c82d4f.zip
37945-894KLEER-PLEX ADVANCED ACNE CARE SYSTEM (SALICYLIC ACID) KIT [BIO-MEDICAL & PHARMACEUTICAL MANUFACTURING CORPORATION]4Legacy NDC20141103_79f8fc90-2447-4224-ac79-1645d1c82d4f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ4
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ4
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L04
ALCOHOLINACTIVE INGREDIENT3K9958V90M4
AMMONIUM LAURYL SULFATEINACTIVE INGREDIENTQ7AO2R1M0B4
BRUCINE SULFATEINACTIVE INGREDIENTKY7O12XPOQ4
DIAZOLIDINYL UREAINACTIVE INGREDIENTH5RIZ3MPW44
GLYCERININACTIVE INGREDIENTPDC6A3C0OX4
GLYCOLIC ACIDINACTIVE INGREDIENT0WT12SX38S4
HYDROXYPROPYL BIS-HYDROXYETHYLDIMONIUM CHLORIDEINACTIVE INGREDIENT1EO3O1X7HG4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO4
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEB4
LAURAMIDOPROPYL BETAINEINACTIVE INGREDIENT23D6XVI2334
MAGNESIUM SULFATEINACTIVE INGREDIENTDE08037SAB4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T4
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH4
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YH4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V34
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH4
TERT-BUTYL ALCOHOLINACTIVE INGREDIENTMD83SFE9594
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK4
WATERINACTIVE INGREDIENT059QF0KO0R4
WHEAT GERM OILINACTIVE INGREDIENT14C97E680P4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 42 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 55 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 9 · 505 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO / TOPICAL0.15 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSYRUP / ORAL250 mgExact identifier — unii candidate
27 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, DELAYED RELEASE / ORAL1.7 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHAEROSOL, FOAM / TOPICAL0.04 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHSOLUTION / DENTAL0.04 %v/vExact identifier — unii candidate
21 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TFILM / BUCCAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL2350 mgExact identifier — unii candidate
29 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / TOPICAL4522 mgExact identifier — unii candidate
81 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR60 mgExact identifier — unii candidate
28 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUSPENSION / ORAL80 mgExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / INTRAVENOUS50.33 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEESUSPENSION / RECTAL452 mgExact identifier — unii candidate
29 equally ranked IID candidates
AMMONIUM LAURYL SULFATEAMMONIUM LAURYL SULFATEQ7AO2R1M0BEMULSION / TOPICAL39.75 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOSHAMPOO / TOPICAL3 %w/wExact identifier — unii candidate
27 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET, CHEWABLE / ORAL1.28 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS15 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AMMONIUM LAURYL SULFATEAMMONIUM LAURYL SULFATEQ7AO2R1M0BAEROSOL / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / TOPICAL24 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHELIXIR / ORAL200 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / VAGINALNAExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / INTRAMUSCULAR95 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXMOUTHWASH / BUCCAL100 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYSTEM / TOPICAL21 mgExact identifier — unii candidate
68 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, ORALLY DISINTEGRATING / ORAL41 mgExact identifier — unii candidate
27 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED / ORAL96 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
68 equally ranked IID candidates
DIAZOLIDINYL UREADIAZOLIDINYL UREAH5RIZ3MPW4CREAM / TOPICAL29 mgExact identifier — unii candidate
3 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOCAPSULE, EXTENDED RELEASE / ORAL119.7 mgExact identifier — unii candidate
27 equally ranked IID candidates
PEPPERMINT OILPEPPERMINT OILAV092KU4JHLOZENGE / ORAL12 mgExact identifier — unii candidate
21 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSPRAY, METERED / NASAL40 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED, EXTENDED RELEASE / ORAL221 mgExact identifier — unii candidate
27 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHCLOTH / TOPICALNAExact identifier — unii candidate
28 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / NASAL26 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii candidate
79 equally ranked IID candidates
POLYSORBATE 20POLYSORBATE 207T1F30V5YHSUPPOSITORY / VAGINALNAExact identifier — unii candidate
28 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / ORAL2 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / VAGINAL3 mgExact identifier — unii candidate
68 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
25c82c9e-09aa-4486-8fa0-a9fb4cd494ba79f8fc90-2447-4224-ac79-1645d1c82d4f2014-11-03WarningsExact identifier
spl id: 25c82c9e-09aa-4486-8fa0-a9fb4cd494ba
spl set id: 79f8fc90-2447-4224-ac79-1645d1c82d4f

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.