Drug Facts

Drug Facts
SPL v12
SPL
SPL Set ID 73b914a1-67dc-40c9-9fc8-e8cb17599571
Route
TOPICAL
Published
Effective Date 2010-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (0.95 g)
Inactive Ingredients
Water Sodium Laureth Sulfate Cocamidopropyl Betaine Carbomer 1342 Glycerin Laureth-7 Carboxymethylcellulose Sodium Sodium Hydroxide Dmdm Hydantoin Sodium Chloride

Identifiers & Packaging

Pill Appearance
Color: blue Color: yellow
Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-12-20
Description

Active Ingredient -  Pyrithione Zinc 0.95%

Medication Information

Warnings and Precautions

Warnings   For external use only

Indications and Usage
Use    Helps prevent recurrence of flaking and itching associated with dandruff
Dosage and Administration

Directions

  • For best results use at least twice a week or as directed by a doctor.
  • Wet hair and body, massage on to scalp and affected areas in place of your regular soap or body wash,rinse,and repeat if desired.



Description

Active Ingredient -  Pyrithione Zinc 0.95%

Section 50565-1
Keep out of reach of children if swallowed get medical help or contact a poison control center right away.

Section 50567-7

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

Section 50569-3
Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.
Section 51727-6



Inactive ingredients WATER SODIUM LAURETH SULFATE,COCAMIDOPROPYL BETAINE,ACRYLATES COPOLYMER,GLYCERIN, FRAGRANCE,PEG-7 GLYCERYL COCOATE, POLYQUATERNIUM-7,SODIUM POLYNAPHTHALENESULFONATE,CELLULOSE GUM,SODIUM HYDROXIDE,DMDM HYDANTOIN,SODIUM CHLORIDE,CITRIC ACID,BLUE 1,YELLOW5.



Section 51945-4



dialformen-16 oz



                  



dialformen-21 oz

     

Section 53413-1




Questions? 1-800-258-DIAL(3425)















Section 55105-1
Purpose  -   Anti dandruff





Advanced Pyrithione Zinc formula provides a head-to-toe clean.

Helps prevent flakes and relieves scalp itch,dryness, and irritation.
Section 55106-9

Active Ingredient -  Pyrithione Zinc 0.95%

Structured Label Content

Indications and Usage (34067-9)
Use    Helps prevent recurrence of flaking and itching associated with dandruff
Dosage and Administration (34068-7)

Directions

  • For best results use at least twice a week or as directed by a doctor.
  • Wet hair and body, massage on to scalp and affected areas in place of your regular soap or body wash,rinse,and repeat if desired.



Warnings and Precautions (34071-1)

Warnings   For external use only

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 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)
Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.
Section 51727-6 (51727-6)



Inactive ingredients WATER SODIUM LAURETH SULFATE,COCAMIDOPROPYL BETAINE,ACRYLATES COPOLYMER,GLYCERIN, FRAGRANCE,PEG-7 GLYCERYL COCOATE, POLYQUATERNIUM-7,SODIUM POLYNAPHTHALENESULFONATE,CELLULOSE GUM,SODIUM HYDROXIDE,DMDM HYDANTOIN,SODIUM CHLORIDE,CITRIC ACID,BLUE 1,YELLOW5.



Section 51945-4 (51945-4)



dialformen-16 oz



                  



dialformen-21 oz

     

Section 53413-1 (53413-1)




Questions? 1-800-258-DIAL(3425)















Section 55105-1 (55105-1)
Purpose  -   Anti dandruff





Advanced Pyrithione Zinc formula provides a head-to-toe clean.

Helps prevent flakes and relieves scalp itch,dryness, and irritation.
Section 55106-9 (55106-9)

Active Ingredient -  Pyrithione Zinc 0.95%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:12.888596 · Updated: 2026-03-14T22:52:35.540850