zinc therapy soap

SPL v4

SPL

SPL Set ID 637851c6-ff4a-8bbc-e053-2991aa0a963c

Route

topical

Published

Effective Date 2018-02-02

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

pyrithione zinc (2 g)

Inactive Ingredients

sodium chloride citric acid monohydrate water potassium cocoate glycerin oatmeal potassium oleate olive oil coco glucoside

Identifiers & Packaging

Marketing Status

otc monograph drug active Since 2018-01-23

Description

Drug Facts

Medication Information

Warnings and Precautions

Warnings

For external use only

Active Ingredient

Active ingredient

Pyrithione zinc 2%

Indications and Usage

Uses

Controls, reduces, and helps stop the symptoms of dandruff and seborrheic dermatitis.

Dosage and Administration

Directions

Shake before each use
Use on affected areas in place of your regular soap
For best results use at least twice a week or as directed by a doctor
Work up a lather using warm water and massage into affected areas
Rinse well

Description

Drug Facts

Section 42229-5

Drug Facts

Section 44425-7

Other information

Store at room temperature
Lot number and expiration date can be found on the bottom of this container

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor ifcondition worsens or does not improve after regular use as directed.

Section 50567-7

When using this productavoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Section 50569-3

Ask a doctor before use if you haveseborrheic dermatitis that covers a large portion of the body.

Section 51727-6

Inactive ingredients

Water, potassium cocoate, potassium oleate, olive oil, vegetable glycerin, coco glucoside, salt, oatmeal, citric acid

Section 51945-4

dermaharmony

Zinc Therapy SOAP

2% Pyrithione Zinc for Seborrheic Dermatitis & Anti-Dandruff

MEDICATED NATURAL CASTILE SOAP

4 FL OZ (118 ml)

Section 53413-1

Questions?

1-800-827-3730

www.dermaharmony.com

Section 55105-1

Purposes

Dandruff, Seborrheic dermatitis

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active ingredient

Pyrithione zinc 2%

Indications and Usage (34067-9)

Uses

Controls, reduces, and helps stop the symptoms of dandruff and seborrheic dermatitis.

Dosage and Administration (34068-7)

Directions

Shake before each use
Use on affected areas in place of your regular soap
For best results use at least twice a week or as directed by a doctor
Work up a lather using warm water and massage into affected areas
Rinse well

Section 42229-5 (42229-5)

Drug Facts

Section 44425-7 (44425-7)

Other information

Store at room temperature
Lot number and expiration date can be found on the bottom of this container

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor ifcondition worsens or does not improve after regular use as directed.

Section 50567-7 (50567-7)

When using this productavoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Section 50569-3 (50569-3)

Ask a doctor before use if you haveseborrheic dermatitis that covers a large portion of the body.

Section 51727-6 (51727-6)

Inactive ingredients

Water, potassium cocoate, potassium oleate, olive oil, vegetable glycerin, coco glucoside, salt, oatmeal, citric acid

Section 51945-4 (51945-4)

dermaharmony

Zinc Therapy SOAP

2% Pyrithione Zinc for Seborrheic Dermatitis & Anti-Dandruff

MEDICATED NATURAL CASTILE SOAP

4 FL OZ (118 ml)

Section 53413-1 (53413-1)

Questions?

1-800-827-3730

www.dermaharmony.com

Section 55105-1 (55105-1)

Purposes

Dandruff, Seborrheic dermatitis

Advanced Ingredient Data

[{"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM COCOATE", "unii": "F8U72V8ZXP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OATMEAL", "unii": "8PI54V663Y", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POTASSIUM OLEATE", "unii": "74WHF607EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "OLIVE OIL", "unii": "6UYK2W1W1E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "COCO GLUCOSIDE", "unii": "ICS790225B", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PYRITHIONE ZINC", "unii": "R953O2RHZ5", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "100", "strengthNumeratorUnit": "g", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"34067-9": "Uses Controls, reduces, and helps stop the symptoms of dandruff and seborrheic dermatitis.", "34068-7": "Directions Shake before each use Use on affected areas in place of your regular soap For best results use at least twice a week or as directed by a doctor Work up a lather using warm water and massage into affected areas Rinse well", "34071-1": "Warnings For external use only", "42229-5": "Drug Facts", "44425-7": "Other information Store at room temperature Lot number and expiration date can be found on the bottom of this container", "50565-1": "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.", "50566-9": "Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.", "50567-7": "When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.", "50569-3": "Ask a doctor before use if you have seborrheic dermatitis that covers a large portion of the body.", "51727-6": "Inactive ingredients Water, potassium cocoate, potassium oleate, olive oil, vegetable glycerin, coco glucoside, salt, oatmeal, citric acid", "51945-4": "dermaharmony Zinc Therapy SOAP 2% Pyrithione Zinc for Seborrheic Dermatitis & Anti-Dandruff MEDICATED NATURAL CASTILE SOAP 4 FL OZ (118 ml)", "53413-1": "Questions? 1-800-827-3730 www.dermaharmony.com", "55105-1": "Purposes Dandruff, Seborrheic dermatitis", "55106-9": "Active ingredient Pyrithione zinc 2%"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:04:57.770332 · Updated: 2026-03-14T23:06:11.878508