ESIKA

Manufacturer
Ventura Corporation Ltd | Bel Star S.A. (Colombia)
Effective date
2012-01-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:49:46

Label at a glance#

ProductESIKA MEN MAXIMUM STRENGTH
Active ingredientPYRITHIONE ZINC
Label structure9 sections

Indications and uses

Reduces the symptoms of dandruff

Dosage and administration

For best results use at least twice a week or as directed by a doctor.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

ZINC PYRITHIONE 0.528 %

Purpose

OTC - PURPOSE SECTION

Antidandruff shampoo

Uses

INDICATIONS & USAGE SECTION

Reduces the symptoms of dandruff

Warnings

WARNINGS SECTION

For external use only

Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - ASK DOCTOR SECTION

If condition worsens or does not improve after regular use of this product as directed, consult a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

For best results use at least twice a week or as directed by a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, SODIUM LAURETH SULFATE, COCAMIDE DEA, COCAMIDOPROPYL BETAINE, DIMETHICONOL, GLYCOL DISTEARATE, HYDROLYZED SOY PROTEIN, SODIUM CHLORIDE, FRAGRANCE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, TRIETHANOLAMINE, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, COCO-GLUCOSIDE, HYDROLYZED WHEAT PROTEIN, TEA-DODECYLBENZENESULFONATE, GLYCERYL OLEATE, GLYCERYL STEARATE, CI 77891 (TITANIUM DIOXIDE ), MAGNESIUM NITRATE, CITRIC ACID, HYDROLYZED RICE PROTEIN, ZINC CHLORIDE, BUTYLENE GLYCOL, CI 19140 (YELLOW 5), PANTHENOL, HYDROLYZED CORN PROTEIN, MENTHYL PCA, METHYLCHLOROISOTHIAZOLINONE, MENTHA AQUATICA LEAF EXTRACT, PROPYLENE GLYCOL, MAGNESIUM CHLORIDE, SACCHAROMYCES/MAGNESIUM FERMENT, CI 14700 (RED 4), PPG-26-BUTETH-26, METHYLISOTHIAZOLINONE, PEG-40 HYDROGENATED CASTOR OIL, MENTHOL, DIPROPYLENE GLYCOL, SACCHAROMYCES/IRON FERMENT, SACCHAROMYCES/COPPER FERMENT, SACCHAROMYCES/SILICON FERMENT, SACCHAROMYCES/ZINC FERMENT, CI 42090 (BLUE 1), APIGENIN, BIOTINOYL TRIPEPTIDE-1, OLEANOLIC ACID

SPL UNCLASSIFIED SECTION

Puerto Rico: Distribuited by Ventura Corporation Ltd., San Juan, Puerto Rico 00924.

PRINCIPAL DISPLAY PANEL - 300 ml Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MEN

shampoo

Maximum Strength

  • Nourishes* and moisturizes hair
  • Prevents dandruff
  • Provides maximum cleaning
    *due to strengthening

ēsika

300 ml e (10.1 fl.oz)

PRINCIPAL DISPLAY PANEL - 300 ml Bottle
PRINCIPAL DISPLAY PANEL - 300 ml Bottle

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
13537-154-012025-04-30C16284748780-197449f38-c7d9-f6ea-e053-dbdaa90aa703ESIKA MEN SHAMPOO MAXIMUM STRENGTH
13537-154-012019-11-13C16284748780-197449f38-c7d9-f6ea-e053-dbdaa90aa703ESIKA MEN SHAMPOO MAXIMUM STRENGTH

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PYRITHIONE ZINCACTIVE INGREDIENTR953O2RHZ51
PYRITHIONE ZINCACTIVE MOIETYR953O2RHZ51
APIGENININACTIVE INGREDIENT7V515PI7F61
BIOTINOYL TRIPEPTIDE-1INACTIVE INGREDIENTO6380721VA1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX1
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972D1
COCO GLUCOSIDEINACTIVE INGREDIENTICS790225B1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C401
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C RED NO. 4INACTIVE INGREDIENTX3W0AM1JLX1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1M1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
GLYCOL DISTEARATEINACTIVE INGREDIENT13W7MDN21W1
MAGNESIUM CHLORIDEINACTIVE INGREDIENT02F3473H9O1
MAGNESIUM NITRATEINACTIVE INGREDIENT77CBG3UN781
MENTHA AQUATICA LEAFINACTIVE INGREDIENT5M106ME6PT1
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1
MENTHYL PYRROLIDONE CARBOXYLATE, (-),DL-INACTIVE INGREDIENT8P18J856U21
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPN1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA1
OLEANOLIC ACIDINACTIVE INGREDIENT6SMK8R7TGJ1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
POLYOXYL 40 HYDROGENATED CASTOR OILINACTIVE INGREDIENT7YC686GQ8F1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP01
TEA-DODECYLBENZENESULFONATEINACTIVE INGREDIENT8HM7ZD48HN1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1
ZINC CHLORIDEINACTIVE INGREDIENT86Q357L16B1

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13537-15413537-154-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 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
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE, EXTENDED RELEASE / ORAL41 mgExact identifier — unii candidate
134 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, FILM COATED / ORAL0.16 mgExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SWAB / TOPICAL34.6 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / TOPICAL5148 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOLUTION / AURICULAR (OTIC)0.2 %w/vExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPDROPS / ORALNAExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAMUSCULAR17 mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, COATED / ORAL25 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / INTRAPLEURALADJ PHExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRALESIONAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION / PERIDURALNAExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii candidate
21 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULARNAExact identifier — unii candidate
88 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii candidate
21 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE / ORAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPEMULSION / TOPICAL0.11 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAOCULAR320 mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / AURICULAR (OTIC)10 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL / TOPICAL19.2 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSOAP / TOPICAL0.5 %w/wExact identifier — unii candidate
88 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / ORAL1126 mgExact identifier — unii candidate
134 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSPRAY / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / SUBCUTANEOUS1.4 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
COCO DIETHANOLAMIDECOCO DIETHANOLAMIDE92005F972DSOLUTION / TOPICAL2.5 %w/vExact identifier — unii candidate
5 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / RECTAL0.01 %w/vExact identifier — unii candidate
37 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSPRAY, METERED / NASAL2 mgExact identifier — unii candidate
88 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact identifier — unii candidate
22 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, FILM COATED, EXTENDED RELEASE / ORAL19 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PERIDURAL8.07 mgExact identifier — unii candidate
134 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSOLUTION / ORAL1 mg/1mlExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
DIPROPYLENE GLYCOLDIPROPYLENE GLYCOLE107L85C40SYSTEM / TRANSDERMAL6 mgExact identifier — unii candidate
3 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE PELLETS / ORAL0.01 mgExact identifier — unii candidate
37 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
MAGNESIUM CHLORIDEMAGNESIUM CHLORIDE02F3473H9OSOLUTION/ DROPS / OPHTHALMIC0.03 %w/vExact identifier — unii candidate
7 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKDROPS / NASALNAExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKAEROSOL, METERED / RECTALADJ PHExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / SUBCUTANEOUS0.8 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE / ORAL1072 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / NASAL330 mgExact identifier — unii candidate
134 equally ranked IID candidates
FD&C YELLOW NO. 5FD&C YELLOW NO. 5I753WB2F1MSUSPENSION / ORALNAExact identifier — unii candidate
22 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPTABLET, FILM COATED / ORAL42 mgExact identifier — unii candidate
88 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSYRUP / ORAL0.05 mg/5mlExact identifier — unii candidate
37 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, CHEWABLE / ORAL20 mgExact identifier — unii candidate
134 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPSYSTEM / IONTOPHORESIS0.2 mgExact identifier — unii candidate
88 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS608 mgExact identifier — unii candidate
88 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XJELLY / NASALNAExact identifier — unii candidate
134 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPDROPS / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRALESIONAL13 mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, EXTENDED RELEASE / TRANSDERMAL58.13 mgExact identifier — unii candidate
81 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOAP / TOPICAL0.01 %w/wExact identifier — unii candidate
37 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / SUBMUCOSAL17 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET / ORAL231 mgExact identifier — unii candidate
134 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
3400f5cb-946d-c3ab-e063-6394a90a31228ea70c2d-8818-4845-974d-df1b5d0ddc492025-04-30WarningsExact identifier
spl set id: 8ea70c2d-8818-4845-974d-df1b5d0ddc49

Reported adverse events (FAERS/openFDA)#

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