Moraz Medical Herbs (1989) Limited Drug Facts

Drug Details [pdf]

HERBALISTE- zinc pyrithione shampoo
Moraz Medical Herbs (1989) Limited

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

Zinc Pyrithione 1%

Purpose

Anti-dandruff

Uses

Reduces the symptoms of Dandruff

Warning

For external use only.

When using this product

Keep away from eyes. When in contact with eyes, rinse immediately with water

Stop use and ask a doctor

if condition worsens or does not improve after regular use as directed

Keep out of reach of children

If swallowed, get medical help or contact a poison control center right away.

Inactive ingredients

Lather into hair,leave for 3 minutes, then rinse thoroughly.
For best result use at least twice a week or as directed by a doctor.

Inactive ingredients

Rosmarinus Officinalis(Rosemary) Leaf Extract, Ammonium Laureth Sulfate, Ammonium Lauryl Sulfate, Ammonium Chloride, Sodium Laureth Sulfate, Glycol Distearate, Cocamide MEA, PEG-150 Distearate, Polyquaternium-10, Triethanolamine, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Parfum, Hexyl Cinnamal, Linalool, Benzyl Salicylate, Coumarin, Butylphenyl Methylpropional, Citronellol, Aqua, Methylchloroisothiszolinone and Methylisothiazolinone.

Questions or Comments?

Call +1(914)8108625 Monday through Friday

Principal Display Panel

NDC: 71159-003-50

Herbaliste

PROFESSIONAL HERBAL HAIRCARE

HERBAL SHAMPOO

Anti Dandruff

SLS and Paraben Free

500 ml

Label

HERBALISTE
zinc pyrithione shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71159-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PYRITHIONE ZINC (UNII: R953O2RHZ5) (PYRITHIONE ZINC - UNII:R953O2RHZ5)	PYRITHIONE ZINC	5 g in 500 g

Ingredient Name	Strength
Inactive Ingredients
ROSEMARY (UNII: IJ67X351P9)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
AMMONIUM CHLORIDE (UNII: 01Q9PC255D)
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
PEG-150 DISTEARATE (UNII: 6F36Q0I0AC)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
COUMARIN (UNII: A4VZ22K1WT)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
.BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)
WATER (UNII: 059QF0KO0R)
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 71159-003-50	500 g in 1 BOTTLE; Type 0: Not a Combination Product	03/30/2017	03/30/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	03/30/2017	03/30/2017

Labeler - Moraz Medical Herbs (1989) Limited (600100408)

Revised: 7/2019

Document Id: 04bf4fa5-a18c-4b94-968b-ede9a4ccb587

Set id: 1ea78f50-0100-4ce8-99fd-e2fb2e95616e

Version: 3

Effective Time: 20190718

Moraz Medical Herbs (1989) Limited