FDA.reportPublic FDA data

American Crew Anti-Dandruff plus Sebum Control

Manufacturer
Colomer USA, Ltd. | Tri Tech Laboratories
Effective date
2014-06-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:39:32

Label at a glance#

ProductAmerican Crew Anti-Dandruff plus Sebum Control
Active ingredientPyrithione Zinc
Label structure8 sections

Indications and uses

Controls itching & flaking due to dandruff.

Dosage and administration

Wet hair thoroughly. Massage a small amount of shampoo evenly into scalp and leave on for a few minutes. Rinse well. For best results use at least twice a week or as directed by a physician.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff

Uses

INDICATIONS & USAGE SECTION

Controls itching & flaking due to dandruff.

Warnings

WARNINGS SECTION

  • For external use only.
  • Avoid contact with 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 physician.
  • Consult a physician prior to use in children under 2 years of age.

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

  • Wet hair thoroughly.
  • Massage a small amount of shampoo evenly into scalp and leave on for a few minutes.
  • Rinse well.
  • For best results use at least twice a week or as directed by a physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water) (Eau), Sodium Laureth Sulfate, Acrylates Copolymer, Cocamidopropyl Betaine, Glycerin, PEG-12 Dimethicone, Di-PPG-2 Myreth-10 Adipate, Triethanolamine, Hydroxyethylcellulose, Propylene Glycol, Sodium Chloride, Polyquaternium-7, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Mentha Piperita (Peppermint) Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Sodium Acetate, Parfum (Fragrance), Limonene, Phenoxyethanol, Ethylparaben, Methylparaben, Methylchloroisothiazolinone, Methylisothiazolinone

PRINCIPAL DISPLAY PANEL - 250mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AMERICAN
CREW®
TRICHOLOLGY

Official Supplier to Men™

ANTI-DANDRUFF +
SEBUM CONTROL
SHAMPOO

Anti-dandruff + sebum
control shampoo with
conditioning properties

250mL e / 8.4 Fl. Oz.

Principal Display Panel - 250mL Bottle Label
Principal Display Panel - 250mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN2
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD2
209884zinc pyrithione 1 % Medicated ConditionerSY2
209884zinc pyrithione 1 % Medicated ShampooSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42743-4700-12019-11-27C16284748780-19855e2a2-4788-60a7-e053-dbdaa90a05bdAmerican Crew ® Anti-Dandruff + Sebum Control Shampoo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42743-4700-1American Crew Anti-Dandruff plus Sebum Control250 mL in 1 BOTTLESHAMPOO2502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42743-4700AMERICAN CREW ANTI-DANDRUFF PLUS SEBUM CONTROL (PYRITHIONE ZINC) SHAMPOO [COLOMER USA, LTD.]2Legacy NDC, 1 package rows20140612_7e62cb98-d03d-4091-824b-7406583d871f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Pyrithione ZincACTIVE INGREDIENTR953O2RHZ52
Pyrithione ZincACTIVE MOIETYR953O2RHZ52
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX2
DI-PPG-2 MYRETH-10 ADIPATEINACTIVE INGREDIENT4IN301M0KJ2
ETHYLPARABENINACTIVE INGREDIENT14255EXE392
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)INACTIVE INGREDIENTR33S7TK2EP2
LIMONENE, (+)-INACTIVE INGREDIENTGFD7C86Q1W2
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPN2
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFA2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
PEG-12 DIMETHICONE (300 CST)INACTIVE INGREDIENTZEL54N6W952
PEPPERMINT OILINACTIVE INGREDIENTAV092KU4JH2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)INACTIVE INGREDIENT0L414VCS5Y2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
ROSEMARYINACTIVE INGREDIENTIJ67X351P92
SAGEINACTIVE INGREDIENT065C5D077J2
SODIUM ACETATEINACTIVE INGREDIENT4550K0SC9B2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8X2
SODIUM LAURETH-3 SULFATEINACTIVE INGREDIENTBPV390UAP02
TEA TREE OILINACTIVE INGREDIENTVIF565UC2G2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK2

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42743-470042743-4700-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
Pyrithione ZincR953O2RHZ5ACTIB
SODIUM LAURETH-3 SULFATEBPV390UAP0IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
GLYCERINPDC6A3C0OXIACT
PEG-12 DIMETHICONE (300 CST)ZEL54N6W95IACT
DI-PPG-2 MYRETH-10 ADIPATE4IN301M0KJIACT
TROLAMINE9O3K93S3TKIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM CHLORIDE451W47IQ8XIACT
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW)0L414VCS5YIACT
TEA TREE OILVIF565UC2GIACT
PEPPERMINT OILAV092KU4JHIACT
ROSEMARYIJ67X351P9IACT
SAGE065C5D077JIACT
SODIUM ACETATE4550K0SC9BIACT
LIMONENE, (+)-GFD7C86Q1WIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLPARABEN14255EXE39IACT
METHYLPARABENA2I8C7HI9TIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT

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 8 · 464 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBMUCOSAL16 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSPRAY / TOPICAL0.2 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / TOPICAL0.16 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKINJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS0.02 %w/vExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSUSPENSION/ DROPS / AURICULAR (OTIC)0.03 %w/vExact identifier — unii candidate
32 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAVENOUS16624 mgExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXPASTE, DENTIFRICE / DENTAL18 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUPPOSITORY / RECTAL140 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
LIMONENE, (+)-LIMONENE, (+)-GFD7C86Q1WGEL / TOPICAL10 mgExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSYRUP / ORAL40 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / TOPICAL0.32 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION/ DROPS / TOPICAL0.75 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVESICAL351 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAMUSCULAR7459 mgExact identifier — unii candidate
81 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / VAGINAL8 mgExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTERIAL278 mgExact identifier — unii candidate
134 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKEMULSION / TOPICAL0.5 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / DENTAL0.4 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, FOAM / RECTAL1214 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRACAUDAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSOLUTION/ DROPS / AURICULAR (OTIC)0.03 %w/wExact identifier — unii candidate
32 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ENDOTRACHEAL46.76 mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET, COATED / ORAL16 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL1.35 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3LOTION / TOPICAL3392 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / OPHTHALMIC0.6 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / SUBMUCOSAL17 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XCAPSULE, EXTENDED RELEASE / ORAL41 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XTABLET, COATED / ORAL54.7 mgExact identifier — unii candidate
134 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
79 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / VAGINAL750 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSOLUTION / TOPICAL210 mgExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / DENTALNAExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TAMPON / VAGINAL62.1 mgExact identifier — unii candidate
81 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKLIQUID / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BSOLUTION / TOPICALNAExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / RETROBULBAR648 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BLIQUID / INTRAVENOUS0.2 %w/vExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVENOUS2916 mgExact identifier — unii candidate
134 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TPOWDER / ORALNAExact identifier — unii candidate
79 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XLIQUID / INTRAMUSCULAR17 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM ACETATESODIUM ACETATE4550K0SC9BINJECTION / INTRAMUSCULAR19 mgExact identifier — unii candidate
32 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAMUSCULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
SODIUM CHLORIDESODIUM CHLORIDE451W47IQ8XINJECTION / PARENTERAL584 mgExact identifier — unii candidate
134 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL, METERED / TRANSDERMAL14 mgExact identifier — unii candidate
22 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
605ebeb6-c4ad-4c3e-8a6d-e15b63041dda7e62cb98-d03d-4091-824b-7406583d871f2014-06-11WarningsExact identifier
spl id: 605ebeb6-c4ad-4c3e-8a6d-e15b63041dda
spl set id: 7e62cb98-d03d-4091-824b-7406583d871f

Reported adverse events (FAERS/openFDA)#

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