ALOE COAL 01- pyrithione zinc liquid

Aloe Coal 01 by

Drug Labeling and Warnings

Aloe Coal 01 by is a Otc medication manufactured, distributed, or labeled by T. SPRUILL, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

ACTIVE INGREDIENT:

Pyrithione Zinc 1.00%

PURPOSE

Dandruff Treatment

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.

When using this product

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

Stop and ask a doctor 

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

Keep out of reach of children.

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

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.

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

Package Labeling:

INGREDIENTS AND APPEARANCE

ALOE COAL 01 
pyrithione zinc liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73324-091
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
ARGAN OIL (UNII: 4V59G5UW9X)
OAT (UNII: Z6J799EAJK)
BIOTIN (UNII: 6SO6U10H04)
GRAPEFRUIT (UNII: O82C39RR8C)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DIMETHICONE (UNII: 92RU3N3Y1O)
EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
JOJOBA OIL (UNII: 724GKU717M)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73324-091-08	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	08/26/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358H	08/26/2019

Labeler - T. SPRUILL, LLC (117054436)