SPL v1
SPL
SPL Set ID ab084d44-dfb8-4cde-bfa1-17d72cce686e
Route
TOPICAL
Published
Effective Date 2013-10-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (20 mg)
Inactive Ingredients
Water Sodium Laureth Sulfate Cocamidopropyl Betaine Sodium Chloride Coco Monoethanolamide .beta.-d-glucopyranose Glycerin Carbomer Copolymer Type A Dmdm Hydantoin Trolamine Edetate Disodium Fd&c Blue No. 1

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-10-09

Description

Active Ingredient                              Purpose Pyrithione zinc 0.5% .................. Anti-dandruff


Medication Information

Warnings and Precautions

WARNINGS

For external use only

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.

Indications and Usage

Uses helps prevent recurrence of flaking and itching associated with dandruff.

Gentle enough for everyday use. For best results, use with XtraCare nourishing coconut & shea butter conditioner.

Dosage and Administration

Directions

Wet hair, massage onto scalp, rinse. Repeat if desired. For best results use at least twice a week or as directed by a doctor.

Description

Active Ingredient                              Purpose Pyrithione zinc 0.5% .................. Anti-dandruff

Section 50565-1

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

Section 51727-6

Inactive Ingredients

water, sodium laureth sulfate, cocamidopropyl betaine, sodium chloride, cocamide MEA, lauryl methyl gluceth-10, glycerin, carbomer, DMDM hydantoin, fragrance, triethanolamine, disodium EDTA, cocos nucifera (coconut) fruit extract, shea nut butter.

Section 51945-4

Section 55105-1

XtraCare Anti-Dandruff Shampoo + pyrithione zinc

nourishing coconut & shea butter

fight flakes leaving hair healthy & shiny

Section 55106-9

Active Ingredient                              Purpose

Pyrithione zinc 0.5% .................. Anti-dandruff

Section 60561-8

Other information

store at 20°C to 25°C (68° to 77°F)


Structured Label Content

Indications and Usage (34067-9)

Uses helps prevent recurrence of flaking and itching associated with dandruff.

Gentle enough for everyday use. For best results, use with XtraCare nourishing coconut & shea butter conditioner.

Dosage and Administration (34068-7)

Directions

Wet hair, massage onto scalp, rinse. Repeat if desired. For best results use at least twice a week or as directed by a doctor.

Warnings and Precautions (34071-1)

WARNINGS

For external use only

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.

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 51727-6 (51727-6)

Inactive Ingredients

water, sodium laureth sulfate, cocamidopropyl betaine, sodium chloride, cocamide MEA, lauryl methyl gluceth-10, glycerin, carbomer, DMDM hydantoin, fragrance, triethanolamine, disodium EDTA, cocos nucifera (coconut) fruit extract, shea nut butter.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

XtraCare Anti-Dandruff Shampoo + pyrithione zinc

nourishing coconut & shea butter

fight flakes leaving hair healthy & shiny

Section 55106-9 (55106-9)

Active Ingredient                              Purpose

Pyrithione zinc 0.5% .................. Anti-dandruff

Section 60561-8 (60561-8)

Other information

store at 20°C to 25°C (68° to 77°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)