SPL v2
SPL
SPL Set ID cdd3c52e-4c32-46c1-bdb3-957b164190bb
Route
TOPICAL
Published
Effective Date 2024-12-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (0.0095 g)
Inactive Ingredients
Water Glycerin Sodium Lauroyl Methyl Isethionate Cocamidopropyl Hydroxysultaine Acrylic Acid/isophorone Diisocyanate/peg-27 Copolymer Apple Phenoxyethanol Sodium Chloride Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) Sodium Hydroxide Glycyrrhizinate Dipotassium Panthenol Ethylhexylglycerin Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-13

Description

Drug Facts

Purpose

Seborrheic Dermatitis and Dandruff


Medication Information

Purpose

Seborrheic Dermatitis and Dandruff

Description

Drug Facts

Uses

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

Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

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

Section 50567-7

When using this product• avoid contact with eyes.

If contact occurs, rinse eyes thoroughly with water.

Section 50569-3

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

Warnings

For external use only.

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.
Active Ingredient

Pyrithione Zinc 0.95%

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.)


Structured Label Content

Uses

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

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product• avoid contact with eyes.

If contact occurs, rinse eyes thoroughly with water.

Section 50569-3 (50569-3)

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

Purpose

Seborrheic Dermatitis and Dandruff

Warnings

For external use only.

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.
Active Ingredient (Active ingredient)

Pyrithione Zinc 0.95%

Inactive Ingredients (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 (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.)


Advanced Ingredient Data


Raw Label Data

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