keracare dry and itchy scalp anti-dandruff moisturizing conditioner

keracare dry and itchy scalp anti-dandruff moisturizing conditioner
SPL v7
SPL
SPL Set ID 5d501ba0-a6f9-4f0d-86d5-0e8d9302737f
Route
topical
Published
Effective Date 2020-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
pyrithione zinc (10 mg)
Inactive Ingredients
coconut oil betaine aloe vera leaf cetostearyl alcohol piroctone ppg-1 trideceth-6 propanediol caprylyl glycol salicylic acid .alpha.-hexylcinnamaldehyde phenoxyethanol linalool, (+/-)- glycerin stearamidopropyl dimethylamine menthol propylene glycol dicaprylate/dicaprate dipropylene glycol citric acid monohydrate water flax seed 2-(cyclohexylamino)ethanesulfonic acid cetyl alcohol behentrimonium chloride

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2009-06-18 Until 2027-05-23

Purpose

Anti-Dandruff, Anti-Seborrheic Dermatitis

Description

Pyrithione Zinc 1%


Medication Information

Warnings

■ For external use only

-----------------------------------------------------------------------------------------------------

Indications and Usage

Use for the relief of scalp flaking, itching and irritation associated with

dandruff and seborrheic dermatitis.

Purpose

Anti-Dandruff, Anti-Seborrheic Dermatitis

Directions

For best results, shampoo first with KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing

Shampoo. Distribute KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing Conditioner

throughout hair and cover with a plastic cap. Leave on a few minutes and rinse thoroughly. Style

as usual.

Inactive Ingredients

Aqua/Water/Eau, Cocos Nucifera (Coconut) Oil, Betaine, Aloe Barbadensis Leaf Juice, Cetearyl

Alcohol, Cetyl Alcohol, Glycerin, Stearamidopropyl Dimethylamine, Behentrimonium Chloride,

Linum Usitatissimum (Linseed) Seed Extract, Quaternium-80, Piroctone Olamine, Menthol,

Polyquaternium-37, Propylene Glycol Dicaprylate/Dicaprate, PPG-1 Trideceth-6,

Fragrance/Parfum, Polyquaternium-10, Dipropylene Glycol, Propanediol, Caprylyl Glycol,

Phenoxyethanol, Citric Acid, Polyacrylamide, Benzyl Salicylate, Hexyl Cinnamal, Linalool.

Description

Pyrithione Zinc 1%

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 if

■ Condition worsens or does not improve with regular use.

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Section 50567-7

When using this product

■ Avoid getting into eyes. In event of contact, rinse eyes thoroughly with water.

■ Use caution in exposing skin to sunlight after applying this product. It may

increase your tendency to sunburn for up to 24 hours after application.

-----------------------------------------------------------------------------------------------------

Section 50569-3

Ask a doctor before use if you have

■ seborrheic dermatitis that covers large areas of your body.

-----------------------------------------------------------------------------------------------------

Section 51945-4

KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Conditioner

Product NDC 63766-003

Active Ingredient

Pyrithione Zinc 1%


Structured Label Content

Warnings

■ For external use only

-----------------------------------------------------------------------------------------------------

Indications and Usage (34067-9)

Use for the relief of scalp flaking, itching and irritation associated with

dandruff and seborrheic dermatitis.

Purpose

Anti-Dandruff, Anti-Seborrheic Dermatitis

Directions

For best results, shampoo first with KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing

Shampoo. Distribute KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing Conditioner

throughout hair and cover with a plastic cap. Leave on a few minutes and rinse thoroughly. Style

as usual.

Inactive Ingredients

Aqua/Water/Eau, Cocos Nucifera (Coconut) Oil, Betaine, Aloe Barbadensis Leaf Juice, Cetearyl

Alcohol, Cetyl Alcohol, Glycerin, Stearamidopropyl Dimethylamine, Behentrimonium Chloride,

Linum Usitatissimum (Linseed) Seed Extract, Quaternium-80, Piroctone Olamine, Menthol,

Polyquaternium-37, Propylene Glycol Dicaprylate/Dicaprate, PPG-1 Trideceth-6,

Fragrance/Parfum, Polyquaternium-10, Dipropylene Glycol, Propanediol, Caprylyl Glycol,

Phenoxyethanol, Citric Acid, Polyacrylamide, Benzyl Salicylate, Hexyl Cinnamal, Linalool.

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 if

■ Condition worsens or does not improve with regular use.

-----------------------------------------------------------------------------------------------------

Section 50567-7 (50567-7)

When using this product

■ Avoid getting into eyes. In event of contact, rinse eyes thoroughly with water.

■ Use caution in exposing skin to sunlight after applying this product. It may

increase your tendency to sunburn for up to 24 hours after application.

-----------------------------------------------------------------------------------------------------

Section 50569-3 (50569-3)

Ask a doctor before use if you have

■ seborrheic dermatitis that covers large areas of your body.

-----------------------------------------------------------------------------------------------------

Section 51945-4 (51945-4)

KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Conditioner

Product NDC 63766-003

Active Ingredient

Pyrithione Zinc 1%


Advanced Ingredient Data


Raw Label Data

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