FDA.reportPublic FDA data

Facial Fortress

Manufacturer
Pediatric Solutions, LLC | kdc/one Chatsworth, Inc.
Effective date
2025-10-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:38:42

Label at a glance#

ProductFacial Fortress
Active ingredientPYRITHIONE ZINC
Label structure8 sections

Indications and uses

Helps eliminate scalp and skin scaling, redness, flaking, itching, and irritation associated with dandruff and seborrheic dermatitis.

Dosage and administration

For best results use at least twice a week or as directed by a doctor. Wet hair thoroughly, massage on to scalp and skin, rinse.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Pyrithione Zinc 0.95%

Purpose

OTC - PURPOSE SECTION

Seborrheic Dermatitis and Dandruff

Uses

INDICATIONS & USAGE SECTION

Helps eliminate scalp and skin scaling, redness, flaking, itching, and irritation associated with dandruff and seborrheic dermatitis.

Warnings

WARNINGS SECTION

For external use only.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have• seborrheic dermatitis covering a large area of the body.

OTC - WHEN USING SECTION

When using this product• avoid contact with eyes.

If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

Stop use and ask a doctor if• condition worsens or does not improve after regular use of this product as directed.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or call 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.

  • Wet hair thoroughly, massage on to scalp and skin, rinse.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Glycerin, Sodium Lauroyl Methyl Isethionate, Sodium Laurylglucosides Hydroxypropylsulfonate, Cocamidopropyl Hydroxysultaine, Acrylates Copolymer, Pyrus Malus (Apple) Fruit Extract, Phenoxyethanol, Sodium Chloride, Guar Hydroxypropyltrimonium Chloride, Sodium Hydroxide, Dipotassium Glycyrrhizate, Panthenol, Ethylhexylglycerin, Citric Acid.

Principal Display Panel – 237 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dr. Eddie's
FACIAL
FORTRESS™
3 in 1
Face, Hair &
Beard Wash

PYRITHIONE ZINC • ANTI-DANDRUFF • DYE FREE • FRAGRANCE FREE
ANTI-SEBORRHEIC DERMATITIS-DERMATOLOGIST TESTED

8 fl. oz. (237 ml.)

Principal Display Panel – 237 mL Bottle Label
Principal Display Panel – 237 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1091088zinc pyrithione 0.95 % Medicated ShampooPSN2
1091088zinc pyrithione 9.5 MG/ML Medicated ShampooSCD2
1091088zinc pyrithione 0.95 % Medicated ShampooSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130860009950177GTIN-13: 0860009950177
EAN-13: 0860009950177
GTIN-12: 860009950177
UPC-A: 860009950177
GTIN storage (14 digits): 00860009950177		fac05-0001-01.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71566-200-08Facial Fortress237 mL in 1 BOTTLE, PLASTICSHAMPOO2372

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71566-20071566-200-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM LAUROYL METHYL ISETHIONATEII6VCD3S6RIACT
COCAMIDOPROPYL HYDROXYSULTAINE62V75NI93WIACT
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMERR0R8I3X29JIACT
APPLEB423VGH5S9IACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM CHLORIDE451W47IQ8XIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCYRRHIZINATE DIPOTASSIUMCA2Y0FE3FXIACT
PANTHENOLWV9CM0O67ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
PYRITHIONE ZINCR953O2RHZ5ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12024-12-09full-release2026-06-01 00:42:35

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
Facial FortressPYRITHIONE ZINCPediatric Solutions, LLCcdd3c52e-4c32-46c1-bdb3-957b164190bb2025-10-08WarningsExact identifier
ndc (package): 71566-200-08
ndc (product): 71566-200
ndc11 (package): 71566020008
spl id: 9e7ed5d6-6bcd-41d9-a604-1e7bb36b5d87
spl set id: cdd3c52e-4c32-46c1-bdb3-957b164190bb

Reported adverse events (FAERS/openFDA)#

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