Pure Kleen

Manufacturer
Arrow-Magnolia International, Inc, | ABC Compounding Co., Inc.
Effective date
2015-04-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:26:58

Label at a glance#

ProductPure Kleen
Active ingredientCHLOROXYLENOL
Label structure10 sections

Label contents#

Full prescribing information#

Drug Facts Box OTC-Active Ingredient Section

OTC - ACTIVE INGREDIENT SECTION

Chloroxylenol 0.3%

Drug Facts Box OTC-Purpose Section

OTC - PURPOSE SECTION

Antiseptic

Drug Facts Box OTC-Indications & Usage Section

INDICATIONS & USAGE SECTION

for hand-washing to decrease bacteria on the skin

Drug Facts Box OTC-Warnings Section

WARNINGS SECTION

For external use only

Drug Facts Box OTC-When Using Section

OTC - WHEN USING SECTION

do not get into eyes

if contact occurs, rinse eyes thoroughly with water

Drug Facts Box OTC-Stop Use Section

OTC - STOP USE SECTION

irritation and redness develop

Drug Facts Box OTC-Keep Out of Reach of Children Section

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

if swallowed, get medical help or contact a Poison Control Center right away

Drug Facts Box OTC-Dosage & Administration Section

DOSAGE & ADMINISTRATION SECTION

  • wet hands and forearms
  • apply 5 milliliters (teaspoonful) or palmful to hands and forearms
  • scrub thoroughly for 1 minute and rinse

Drug Facts Box OTC-Inactive Ingredient Section

INACTIVE INGREDIENT SECTION

water, decyl glucoside, sodium laureth sulfate, cocamide MIPA, propylene glycol, sodium chloride, citric acid, fragrance, FD and C yellow no.5, food red 10

Pure Kleen 6544 1 gal

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

6544F1S6046.jpg  Pure Kleen  1 gal    image of bottle labelimage of bottle label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76016-544-012023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-032023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-052023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-062023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-072023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-082023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-092023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-102023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-112023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-122023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-132023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-142023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-152023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-162023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-172023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-182023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-192023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-202023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-242023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-272023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-282023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-352023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-552023-06-29C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-012020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-032020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-052020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-062020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-072020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-082020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-092020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-102020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-112020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-122020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-132020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-142020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-152020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-162020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-172020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-182020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-192020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-202020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-242020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-272020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-282020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-352020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label
76016-544-552020-01-31C16284748780-19d75b9d0-6cdf-f424-e053-dadaa90a57cePure Kleen 6544 Drug Facts and Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHLOROXYLENOLACTIVE INGREDIENT0F32U78V2Q1
CHLOROXYLENOLACTIVE MOIETY0F32U78V2Q1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
METANIL YELLOWINACTIVE INGREDIENT7SPF5O5BW81
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP01
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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 6 · 310 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SYSTEM / TOPICAL4200 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / SUBCUTANEOUS0.7 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRALESIONAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAMUSCULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPCONCENTRATE / ORAL5.3 mg/1mlExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION/ DROPS / AURICULAR (OTIC)ADJ PHExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO, SUSPENSION / TOPICAL2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRASYNOVIALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, SOLUTION / INTRAMUSCULAR26 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRABURSAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SPRAY, METERED / NASAL240 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INFILTRATION0.02 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / AURICULAR (OTIC)56.55 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
METANIL YELLOWMETANIL YELLOW7SPF5O5BW8SOAP / TOPICAL0.01 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAMUSCULAR7459 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRACARDIAC1.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCREAM / TOPICAL0.4 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVENOUS2916 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INFILTRATION648 mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTERIAL278 mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAOCULAR1 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / IONTOPHORESIS0.6 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / INTRAVENOUS10 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, COATED / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAPERITONEAL0.54 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRASYNOVIAL4 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE / ORAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSUSPENSION, EXTENDED RELEASE / ORAL140.8 mgExact identifier — unii candidate
88 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS63.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION/ DROPS / OPHTHALMIC0.05 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / SUBCUTANEOUS90 mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3PASTE / DENTAL0.5 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / SUBCUTANEOUS0.8 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVENOUS28773 mgExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSPRAY / NASAL9 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION, CONCENTRATE / INTRAVENOUSNAExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPPOWDER, FOR SOLUTION / TOPICALNAExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM LAURETH SULFATESODIUM LAURETH-3 SULFATEBPV390UAP0SPRAY / TOPICAL0.1 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPELIXIR / ORAL100 mg/5mlExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / ENDOTRACHEAL68 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAVASCULARNAExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / RESPIRATORY (INHALATION)108 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / DENTAL0.4 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPOINTMENT / TOPICAL1 mgExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTROCHE / ORAL12 mgExact identifier — unii candidate
88 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
ff463f2e-0513-2298-e053-6394a90a63f19421a965-63e9-4503-9e46-f53ff15cafe12023-06-29WarningsExact identifier
spl set id: 9421a965-63e9-4503-9e46-f53ff15cafe1

Reported adverse events (FAERS/openFDA)#

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