FACIAL FORTRESS- pyrithione zinc shampoo

Facial Fortress by

Drug Labeling and Warnings

Facial Fortress by is a Otc medication manufactured, distributed, or labeled by Pediatric Solutions, LLC, kdc/one Chatsworth, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Pyrithione Zinc 0.95%

Purpose

Seborrheic Dermatitis and Dandruff

Uses

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

Warnings

For external use only.

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

When using this product avoid contact with eyes.

If contact occurs, rinse eyes thoroughly with water.

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

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

Directions

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

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

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.)

INGREDIENTS AND APPEARANCE

FACIAL FORTRESS 
pyrithione zinc shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71566-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	0.0095 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAUROYL METHYL ISETHIONATE (UNII: II6VCD3S6R)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
ACRYLIC ACID/ISOPHORONE DIISOCYANATE/PEG-27 COPOLYMER (UNII: R0R8I3X29J)
APPLE (UNII: B423VGH5S9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
PANTHENOL (UNII: WV9CM0O67Z)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71566-200-08	237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	12/13/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	12/13/2024

Labeler - Pediatric Solutions, LLC (080736513)

Establishment
Name	Address	ID/FEI	Business Operations
kdc/one Chatsworth, Inc.		118542196	manufacture(71566-200)