ANTIBACTERIAL

Manufacturer
TOPCO ASSOCIATES LLC | APOLLO HEALTH AND BEAUTY CARE
Effective date
2011-08-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:29:05

Label at a glance#

ProductANTIBACTERIAL FRESH PEAR
Active ingredientTRICLOSAN
Label structure8 sections

Indications and uses

HELPS REDUCE BACTERIA ON THE SKIN

Dosage and administration

PUMP ONTO DRY HANDS, WORK INTO LATHER AND RINSE THOROUGHLY.

Storage and handling

STORE AT ROOM TEMPERATURE

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

TRICLOSAN 0.46%

PURPOSE

OTC - PURPOSE SECTION

ANTIBACTERIAL

USES

INDICATIONS & USAGE SECTION

HELPS REDUCE BACTERIA ON THE SKIN

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY

WHEN USING THIS PRODUCT

OTC - WHEN USING SECTION

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.

STOP USING THIS PRODUCT AND ASK DOCTOR

OTC - STOP USE SECTION

IF IRRITATION AND REDNESS DEVELOP

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT POISON CONTROL CENTER IMMEDIATELY

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

PUMP ONTO DRY HANDS, WORK INTO LATHER AND RINSE THOROUGHLY.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

STORE AT ROOM TEMPERATURE

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER (AQUA), SODIUM XYLENE SULFONATE, DIPROPYLENE GLYCOL, GLYCERIN, SODIUM PCA, AMMONIUM LAURYL SULFATE, COCAMIDOPROPYL BETAINE, POLYQUATERNIUM-10, FRAGRANCE (PARFUM), DISODIUM PHOSPHATE, CETYL ALCOHOL, ALOE BARBADENSIS LEAF JUICE, CITRIC ACID, METHYLPARABEN, PROPYLPARABEN, GREEN 3 (CI 42053), YELLOW 10 (CI47005)

LABEL COPY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of the labelimage of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1053855triclosan 0.46 % Medicated Liquid SoapPSN1
1053855triclosan 4.6 MG/ML Medicated Liquid SoapSCD1
1053855triclosan 0.46 % Foaming Medicated Hand SoapSY1
1053855triclosan 0.46 % Medicated Liquid SoapSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-184-082020-01-31C16284748780-19d75b9cf-f4f1-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-184-08ANTIBACTERIALFRESH PEAR222 mL in 1 BOTTLE, PUMPSOLUTION2221

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-184ANTIBACTERIAL FRESH PEAR (TRICLOSAN) SOLUTION [TOPCO ASSOCIATES LLC]1Legacy NDC, 1 package rows20110805_3601fe40-ee31-4d16-ade0-b73c70a45e5f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5X1
TRICLOSANACTIVE MOIETY4NM5039Y5X1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
AMMONIUM LAURYL SULFATEINACTIVE INGREDIENTQ7AO2R1M0B1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1S1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
POLYQUATERNIUM-10 (400 CPS AT 2%)INACTIVE INGREDIENTHB1401PQFS1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SODIUM PHOSPHATE, DIBASIC ANHYDROUSINACTIVE INGREDIENT22ADO53M6F1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A21
SODIUM XYLENESULFONATEINACTIVE INGREDIENTG4LZF950UR1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-18436800-184-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 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 7 · 404 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / INTRAMUSCULAR0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRALESIONAL0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSYRUP / ORAL81 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1751 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYSTEM / TOPICAL21 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHELIXIR / ORAL200 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE, LIQUID FILLED / ORAL0.03 mgExact identifier — unii candidate
15 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET, CHEWABLE, EXTENDED RELEASE / ORAL12 mgExact identifier — unii candidate
61 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, COATED / ORAL2.5 mgExact identifier — unii candidate
31 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSHAMPOO / TOPICAL0.07 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCONCENTRATE / INTRAVENOUSADJ PHExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / TOPICAL0.01 %w/wExact identifier — unii candidate
61 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSPRAY / NASAL5 mgExact identifier — unii candidate
61 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SSYRUP / ORAL3.75 mg/5mlExact identifier — unii candidate
15 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS35 mgExact identifier — unii candidate
61 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLINJECTION, SOLUTION / SUBCUTANEOUS25 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1STABLET / ORAL240 mgExact identifier — unii candidate
15 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GGEL / TOPICALNAExact identifier — unii candidate
31 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION/ DROPS / TOPICAL0.14 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCREAM / TOPICAL1 mgExact identifier — unii candidate
61 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCONCENTRATE / ORAL0.03 mg/1mlExact identifier — unii candidate
31 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GGUM, CHEWING / ORAL2 mgExact identifier — unii candidate
31 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRASYNOVIAL3 mgExact identifier — unii candidate
48 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FFILM / SUBLINGUAL6 mgExact identifier — unii candidate
48 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM PYRROLIDONE CARBOXYLATESODIUM PYRROLIDONE CARBOXYLATE469OTG57A2LOTION / TOPICAL42 mgExact identifier — unii candidate
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GCAPSULE, LIQUID FILLED / ORAL1.51 mgExact identifier — unii candidate
31 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
AMMONIUM LAURYL SULFATEAMMONIUM LAURYL SULFATEQ7AO2R1M0BSHAMPOO, SUSPENSION / TOPICAL30 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / SOFT TISSUE0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii candidate
79 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET, DELAYED RELEASE / ORAL1.9 mgExact identifier — unii candidate
31 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAVENOUS5 mgExact identifier — unii candidate
68 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRAMUSCULAR36 mgExact identifier — unii candidate
48 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INTRA-ARTICULAR0.03 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCAPSULE, LIQUID FILLED / ORAL360 mgExact identifier — unii candidate
61 equally ranked IID candidates
FD&C GREEN NO. 3FD&C GREEN NO. 33P3ONR6O1SCAPSULE, DELAYED RELEASE / ORAL5 mgExact identifier — unii candidate
15 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER / ORALNAExact identifier — unii candidate
79 equally ranked IID candidates
AMMONIUM LAURYL SULFATEAMMONIUM LAURYL SULFATEQ7AO2R1M0BAEROSOL / TOPICALNAExact identifier — unii candidate
3 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLTABLET / SUBLINGUAL36 mgExact identifier — unii candidate
61 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TFILM, SOLUBLE / BUCCAL3 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION / INFILTRATION0.35 mgExact identifier — unii candidate
68 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION, CONCENTRATE / ORAL0.2 mg/1mlExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii candidate
79 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
4fc3ce55-8ce2-487c-9623-2ccc41a990ae3601fe40-ee31-4d16-ade0-b73c70a45e5f2011-08-02WarningsExact identifier
spl id: 4fc3ce55-8ce2-487c-9623-2ccc41a990ae
spl set id: 3601fe40-ee31-4d16-ade0-b73c70a45e5f

Reported adverse events (FAERS/openFDA)#

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