Keracare Dry And Itchy Scalp Anti-dandruff Moisturizing Shampoo

Keracare Dry And Itchy Scalp Anti-dandruff Moisturizing Shampoo
SPL v8
SPL
SPL Set ID 6e7524d7-b280-485a-815e-8af078e8acda
Route
TOPICAL
Published
Effective Date 2019-10-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (10 mg)
Inactive Ingredients
Linalool, (+/-)- Water Aloe Vera Leaf Disodium Laureth Sulfosuccinate Cocamidopropyl Betaine Glycerin Polysorbate 20 Sodium Cocoyl Isethionate Caprylyl Glycol Coco Monoisopropanolamide Cetyl Alcohol Apple Propanediol Phenoxyethanol Edetic Acid .alpha.-hexylcinnamaldehyde Menthol Piroctone Lemon Peel Green Tea Leaf Fd&c Blue No. 1 Citric Acid Monohydrate Salicylic Acid Polyquaternium-10 (30000 Mpa.s At 2%) 2-(cyclohexylamino)ethanesulfonic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2009-06-18 Until 2027-06-17

Description

Pyrithione Zinc 1%

Purpose

Anti-Dandruff, Anti-Seborrheic Dermatitis


Medication Information

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

Description

Pyrithione Zinc 1%

Section 43683-2

Dosage and Administration Section

Section 9

10/2019

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.

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

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 Shampoo

Product NDC

63766-002

Warnings

■ For external use only

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

Directions
  • Apply to wet hair and gently lather with fingertips. Rinse and repeat. Leave on 5 minutes. Shampoo with KeraCare® Hydrating Detangling Shampoo for a final sudsing. For best results, follow with KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing Conditioner.
Active Ingredient

Pyrithione Zinc 1%

Inactive Ingredients

Aqua/Water/Eau, Aloe Barbadensis Leaf Juice, Disodium Laureth Sulfosuccinate,

Cocamidopropyl Betaine, Cocamide MIPA, Polysorbate 20, Sodium Cocoyl

Isethionate, Cetyl Alcohol, Glycerin, Menthol, Piroctone Olamine, Pyrus Malus

(Apple) Fruit Extract, Citrus Limon (Lemon) Peel Extract , Camellia Sinensis Leaf

Extract, Fragrance/Parfum, Quaternium-80, Propanediol, Polyquaternium-10,

Caprylyl Glycol, Phenoxyethanol, Tetrasodium EDTA, Citric Acid, Benzyl Salicylate,

Hexyl Cinnamal, Linalool, Blue 1 (CI 42090).


Structured Label Content

Indications and Usage (34067-9)

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

dandruff and seborrheic dermatitis.

Section 43683-2 (43683-2)

Dosage and Administration Section

Section 9

10/2019

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 Shampoo

Product NDC

63766-002

Purpose

Anti-Dandruff, Anti-Seborrheic Dermatitis

Warnings

■ For external use only

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

Directions
  • Apply to wet hair and gently lather with fingertips. Rinse and repeat. Leave on 5 minutes. Shampoo with KeraCare® Hydrating Detangling Shampoo for a final sudsing. For best results, follow with KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing Conditioner.
Active Ingredient

Pyrithione Zinc 1%

Inactive Ingredients

Aqua/Water/Eau, Aloe Barbadensis Leaf Juice, Disodium Laureth Sulfosuccinate,

Cocamidopropyl Betaine, Cocamide MIPA, Polysorbate 20, Sodium Cocoyl

Isethionate, Cetyl Alcohol, Glycerin, Menthol, Piroctone Olamine, Pyrus Malus

(Apple) Fruit Extract, Citrus Limon (Lemon) Peel Extract , Camellia Sinensis Leaf

Extract, Fragrance/Parfum, Quaternium-80, Propanediol, Polyquaternium-10,

Caprylyl Glycol, Phenoxyethanol, Tetrasodium EDTA, Citric Acid, Benzyl Salicylate,

Hexyl Cinnamal, Linalool, Blue 1 (CI 42090).


Advanced Ingredient Data


Raw Label Data

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