ZENOTRI Scalp Essence by CHROMACH Co., Ltd. / SUANN HYANGJANG Co.,LTD

ZENOTRI Scalp Essence by CHROMACH Co., Ltd. / SUANN HYANGJANG Co.,LTD

ZENOTRI Scalp Essence by

Drug Labeling and Warnings

ZENOTRI Scalp Essence by is a Otc medication manufactured, distributed, or labeled by CHROMACH Co., Ltd., SUANN HYANGJANG Co.,LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ZENOTRI SCALP ESSENCE- salicylic acid gel
CHROMACH Co., Ltd.

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.

----------

Active Ingredient

Salicylic acid 0.25%

Purpose

Antidandruff

Use

For the relief of the symptoms of dandruff

Warnings

For external use only

When using this product avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water.

Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed

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

Directions

For best results use at least twice a week or as directed by a doctor.

Apply the essence to all areas where trouble such as dandruff and inflammation on the scalp is absorbed.

Inactive ingredients

Water, Propylene Glycol, Betaine, Ammonium Acryloyldimethyltaurate/VP Copolymer, 1,2-Hexanediol, Caprylyl Glycol, Menthol, Salicylic acid, Disodium EDTA, Panthenol, Arginine, Butylene Glycol, t-Butyl Alcohol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Isopropyl Myristate, Artemisia Princeps Leaf Extract, Panax ginseng root Extract, Ethylhexylglycerin, Copper Tripeptide-1, Palmitoyl Pentapeptide-4, rh-Oligopeptide-1

ZENOTRI Scalp Essence

25mL

ZENOTRI SCALP ESSENCE
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81817-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.06 g in 25 mL

Ingredient Name	Strength
Inactive Ingredients
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.75 mL in 25 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.00007 mL in 25 mL
PANTHENOL (UNII: WV9CM0O67Z)	0.05 mL in 25 mL
TEA TREE OIL (UNII: VIF565UC2G)	0.01 mL in 25 mL
ASIAN GINSENG (UNII: CUQ3A77YXI)	0.001 mL in 25 mL
PREZATIDE COPPER (UNII: 6BJQ43T1I9)	0.000001 mL in 25 mL
NEPIDERMIN (UNII: TZK30RF92W)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)	0.01 mL in 25 mL
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)	0.002 mL in 25 mL
BETAINE (UNII: 3SCV180C9W)	0.5 mL in 25 mL
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)	0.22 mL in 25 mL
1,2-HEXANEDIOL (UNII: TR046Y3K1G)	0.13 mL in 25 mL
CAPRYLYL GLYCOL (UNII: 00YIU5438U)	0.08 mL in 25 mL
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)	0.05 mL in 25 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)	0.02 mL in 25 mL
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)	0.000001 mL in 25 mL
MENTHOL (UNII: L7T10EIP3A)	0.08 mL in 25 mL
WATER (UNII: 059QF0KO0R)	23.02 mL in 25 mL
ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)	0.001 mL in 25 mL
ARGININE (UNII: 94ZLA3W45F)	0.03 mL in 25 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 81817-101-02	1 in 1 CARTON	04/29/2021	05/03/2021
1	NDC: 81817-101-01	25 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part358H	04/29/2021	05/03/2021

Labeler - CHROMACH Co., Ltd. (695030380)

Name	Address	ID/FEI	Business Operations
Establishment
SUANN HYANGJANG Co.,LTD		688210096	manufacture(81817-101)

Revised: 9/2021

Document Id: cafac6e3-096a-7199-e053-2a95a90ab03c

Set id: c09cb2d0-6767-52f4-e053-2995a90ab8ed

Version: 2

Effective Time: 20210901

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.