Aloe + Coal 01 Shampoo

Aloe + Coal 01 Shampoo
SPL v2
SPL
SPL Set ID 40a94657-6722-46b1-87ed-a15bf60ffc7a
Route
TOPICAL
Published
Effective Date 2019-08-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pyrithione Zinc (10 mg)
Inactive Ingredients
Aloe Vera Leaf Water Argan Oil Oat Biotin Grapefruit Cocamidopropyl Betaine Dimethicone Equisetum Arvense Branch Ethylhexylglycerin Glycerin Helianthus Annuus Flowering Top Olea Europaea (olive) Oil Unsaponifiables Lauryl Glucoside Phenoxyethanol Rosa Canina Fruit Jojoba Oil Sodium Cocoyl Isethionate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-08-26

Description

Pyrithione Zinc 1.00%

Purpose

Dandruff Treatment


Medication Information

Purpose

Dandruff Treatment

Description

Pyrithione Zinc 1.00%

Uses:

For relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent chance of recurrence.

Warnings

For external use only.

Directions:
  • Apply shampoo to wet hair by massaging into lather with pads of finger tips. Rinse thoroughly. 
  • For best results, let shampoo sit for 3-5 minutes before rinsing thoroughly. Use a least twice per week, or as directed by physician.
Package Labeling:

Active Ingredient:

Pyrithione Zinc 1.00%

Other Ingredients:

Activated Charcoal Powder, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Avena Sativa (Oat) Protein, Biotin, Citrus Grandis (Grapefruit) Oil, Cocamidopropyl Betaine, Dimethicone, Equisetum Arvense (Horsetail) Extract, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Hydrolyzed Rice Protein, Olea Europaea (Olive) Oil, Lauryl Glucoside, di-Panthenol, Phenoxyethanol, Rosa Canina (Rose Hips) Oil, Simmondsia Chinensis (Jojoba) Oil, Sodium C14-16 Alpha Olefin Sulfonate, Sodium Cocoyl Isethionate, Sodium Lauryl Glucose Carboxylate

Stop and Ask A Doctor 

if condition worsens or does not improve after using this product as directed.

When Using This Product

avoid contact with eyes. If this happens, rinse thoroughly with water.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses: (USES:)

For relief of flaking and itching associated with dandruff and seborrheic dermatitis and to help prevent chance of recurrence.

Purpose (PURPOSE)

Dandruff Treatment

Warnings (WARNINGS)

For external use only.

Directions: (DIRECTIONS:)
  • Apply shampoo to wet hair by massaging into lather with pads of finger tips. Rinse thoroughly. 
  • For best results, let shampoo sit for 3-5 minutes before rinsing thoroughly. Use a least twice per week, or as directed by physician.
Package Labeling:

Active Ingredient: (ACTIVE INGREDIENT:)

Pyrithione Zinc 1.00%

Other Ingredients: (OTHER INGREDIENTS:)

Activated Charcoal Powder, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Avena Sativa (Oat) Protein, Biotin, Citrus Grandis (Grapefruit) Oil, Cocamidopropyl Betaine, Dimethicone, Equisetum Arvense (Horsetail) Extract, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Hydrolyzed Rice Protein, Olea Europaea (Olive) Oil, Lauryl Glucoside, di-Panthenol, Phenoxyethanol, Rosa Canina (Rose Hips) Oil, Simmondsia Chinensis (Jojoba) Oil, Sodium C14-16 Alpha Olefin Sulfonate, Sodium Cocoyl Isethionate, Sodium Lauryl Glucose Carboxylate

Stop and Ask A Doctor  (Stop and ask a doctor )

if condition worsens or does not improve after using this product as directed.

When Using This Product (When using this product)

avoid contact with eyes. If this happens, rinse thoroughly with water.

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

If swallowed, get medical help or contact a Poison Control Center right away.


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