Drug Facts Box

Drug Facts Box
SPL v1
SPL
SPL Set ID 36415ce4-b737-4aeb-9331-a9230dd78bfa
Route
TOPICAL
Published
Effective Date 2010-11-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (1 mL)
Inactive Ingredients
Water Sodium Laureth Sulfate Ammonio Methacrylate Copolymer Type A Polyquaternium-7 (70/30 Acrylamide/dadmac; 1600 Kd) Coco Monoethanolamide Glycol Distearate Cocamidopropyl Betaine Dimethicone Sodium Chloride Edetate Sodium Sodium Hydroxide Citric Acid Monohydrate Dmdm Hydantoin Fd&c Blue No. 1 D&c Red No. 33

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-11-03

Description

Pyrithione Zinc 1%

Purpose

Antidandruff


Medication Information

Purpose
Antidandruff
Description

Pyrithione Zinc 1%

Uses

To help prevent recurrence of flaking and itching associated with dandruff

Warnings

For external use only.

Directions

For maximum dandruff control, use every time you shampoo. Wet hair, massage onto scalp and rinse . Repeat if desired.

Active Ingredient

Pyrithione Zinc 1%

Inactive Ingredients
Water (Aqua), Sodium Laureth Sulfate, Acrylates Copolymer, Polyquaternium-7, Cocamide MEA, Glycol Distearate, Cocamidopropyl Betaine, Fragrance (Parfum), Dimethicone, Sodium Chloride, Tetrasodium EDTA, Sodium Hydroxide, Citric Acid  DMDM Hydantoin, Blue 1 (CI 42090), Red 33 (CI 17200).
When Using This Product

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Keep Out of Reach of Children

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Package Front and Back Labels

blade.jpg

Stop Using This Product and Ask A Doctor If

condition worsens or does not improve after regular use of this product as directed.


Structured Label Content

Uses

To help prevent recurrence of flaking and itching associated with dandruff

Purpose
Antidandruff
Warnings

For external use only.

Directions

For maximum dandruff control, use every time you shampoo. Wet hair, massage onto scalp and rinse . Repeat if desired.

Active Ingredient

Pyrithione Zinc 1%

Inactive Ingredients
Water (Aqua), Sodium Laureth Sulfate, Acrylates Copolymer, Polyquaternium-7, Cocamide MEA, Glycol Distearate, Cocamidopropyl Betaine, Fragrance (Parfum), Dimethicone, Sodium Chloride, Tetrasodium EDTA, Sodium Hydroxide, Citric Acid  DMDM Hydantoin, Blue 1 (CI 42090), Red 33 (CI 17200).
When Using This Product (when using this product)

Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Package Front and Back Labels

blade.jpg

Stop Using This Product and Ask A Doctor If (Stop using this product and ask a doctor if)

condition worsens or does not improve after regular use of this product as directed.


Advanced Ingredient Data


Raw Label Data

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