FDA.reportPublic FDA data

American Crew

Manufacturer
Revlon Consumer Products Corp | REVLON, INC.
Effective date
2024-12-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:50:02

Label at a glance#

ProductAmerican Crew
Active ingredientPYRITHIONE ZINC
Label structure7 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#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients
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.
• 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.
• KEEP OUT OF REACH OF CHILDREN. If
swallowed, get medical help or contact a
Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE 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

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

American Crew 2-In-1 Anti-Dandruff & Sebum Control Shampoo

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
209884zinc pyrithione 1 % Medicated ShampooPSN3
209884zinc pyrithione 10 MG/ML Medicated ShampooSCD3
209884zinc pyrithione 1 % Medicated ConditionerSY3
209884zinc pyrithione 1 % Medicated ShampooSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-650-25American Crew250 mL in 1 CONTAINERSHAMPOO2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10967-650AMERICAN CREW (PYRITHIONE ZINC) SHAMPOO [REVLON CONSUMER PRODUCTS CORP]3Current NDC, Legacy NDC, 1 package rows20250101_9566b567-90be-4803-b940-e6a91750778f.zip

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
10967-65010967-650-25

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
CAPRYLYL GLYCOL00YIU5438UIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
MENTHOLL7T10EIP3AIACT
WATER059QF0KO0RIACT
AMMONIUM LAURYL SULFATEQ7AO2R1M0BIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
DI-PPG-2 MYRETH-10 ADIPATE4IN301M0KJIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM HYDROXIDE55X04QC32IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
CITRIC ACID2968PHW8QPIACT
HYDROXYPROPYL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDEMVW5LK6LFTIACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
PANTHENOLWV9CM0O67ZIACT

Source Document#

Source XML

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
American CrewPYRITHIONE ZINCRevlon Consumer Products Corp9566b567-90be-4803-b940-e6a91750778f2024-12-30WarningsExact identifier
ndc (package): 10967-650-25
ndc (product): 10967-650
ndc11 (package): 10967065025
spl id: 2a843ed5-0b1e-dda7-e063-6294a90aec3c
spl set id: 9566b567-90be-4803-b940-e6a91750778f

Reported adverse events (FAERS/openFDA)#

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