EH HAIR PLUS REGENERATION HAIR CARE- panthenol, niacinamide, menthol, salicylic acid kit

EH Hair Plus Regeneration Hair Care by

Drug Labeling and Warnings

EH Hair Plus Regeneration Hair Care by is a Otc medication manufactured, distributed, or labeled by ECOBIO Medical Institute, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Hair cool shampoo

- Panthenol (0.5%)

- Niacinamide (0.3%)

- Menthol (0.2%)

Hair stick aroma ampoule

- Panthenol (1.5%)

Hair tonic

- Salicylic Acid (0.5%)

- Niacinamide (0.3%)

- Panthenol (0.1%)

- Menthol (0.03%)

Purpose

- hair tonic

- antiseborrheic

Keep out of reach of children

- Do not swallow. In case of accidental ingestion, seek professional assistance.

Uses

Hair cool shampoo

- To recover the scalp condition for healthier hair. To strengthen hair root, give growth stimulation and thicken hair. Keeps scalp clean and fresh.

Hair stick aroma ampoule

- To recover the scalp condition for healthier hair. To strengthen hair root, give growth stimulation and thicken hair. Keeps scalp clean and fresh.

Hair tonic

- Helps to prevent hair loss and give growth stimulation and thicken hair.

Warnings

Warnings
For external use only
Do not use when Your scalp is red, inflamed, irritated or painful
When using this product
- Do not apply on other parts of the body
- Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
- Do not apply directly to wound or open cut.
Stop use and ask doctor if rash or irritation on scalp develops and lasts.

Store at room temperature

Directions

Hair cool shampoo

- Wet hair with lukewarm water and pump 2-4 times and apply on scalp and hair evenly. Massage gently and rinse clean.

Hair stick aroma ampoule

- Roll over scalp evenly from the center when it is needed.

Hair tonic

- Shake well, apply on scalp evenly every day and massage gently with fingertips until it is absorbed enough. Dry hair.

Inactive Ingredients

Hair cool shampoo

- Water, Ammonium Lauryl Sulfate, Ammonium Laureth Sulfate, Sodium Lauroyl Glutamate, Butylene Glycol, Cocamidopropyl Betain, Betaine, Alcohol, Fragrance, Propylene Glycol, Morus Alba Bark Extract, Polyquaternium-10, Sodium chloride, Camellia Sinensis Leaf Extract, Ethylhexylglycerin, Caprylyl Glycol, Allantoin, Arginine, Camellia Japonica Seed Oil, Cinnamomum Camphora (Camphor) Leaf Extract, Saccharomyces/Lycium Chinense Fruit Ferment Extract Filtrate, Tocopheryl Acetate, Beta-Glucan, Glycyrrhiza Glabra (Licorice) Root Extract, Chitosan, Disodium EDTA, Honey, Lysimachia Foenum-graecum Extract, Panax Ginseng Root Extract, Trehalose, Tropolone, Acorus Calamus Root Extract, Sophora Angustifolia Root Extract, Phenoxyethanol, Coix Lacryma-Jobi Ma-yuen Seed Extract, Algae Extract, Ceramide NP, Citric Acid, Paeonia Albiflora Root Extract, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben

Hair stick aroma ampoule

- Water, Aloe Barbadensis Leaf Juice, Butylene Glycol, Betaine, Alcohol Denat., Ginkgo Biloba Leaf Extract, 1,2-Hexanediol, Propylene Glycol, PEG-60 Hydrogenated Castor Oil, Hamamelis Virginiana (Witch Hazel) Extract, Alcohol, Beta-Glucan, Tocopheryl Acetate, Camellia Sinensis Leaf Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Honey, Lonicera Japonica (Honeysuckle) Flower Extract, Pulsatilla Koreana Extract, Portulaca Oleracea Extract, Arginine, Serine, Mentha Arvensis Leaf Extract, Phenoxyethanol, Allantoin, Cinnamomum Camphora (Camphor) Leaf Extract, Citrus Paradisi (Grapefruit) Fruit Extract, Lavandula Angustifolia (Lavender) Oil, Saccharomyces/Lycium Chinense Fruit Ferment Extract Filtrate, Zanthoxylum Piperitum Fruit Extract, Juglans Regia (Walnut) Seed Extract, Sophora Angustifolia Root Extract, Panax Ginseng Root Extract, Polygonum Multiflorum Root Extract, Angelica Dahurica Root Extract, Coix Lacryma-Jobi Ma-yuen Seed Extract, Acorus Calamus Root Extract, Mentha Piperita (Peppermint) Oil, Phellinus Linteus Extract, Angelica Gigas Root Extract, Disodium EDTA, Lysimachia Foenum-graecum Extract, Chamomilla Recutita (Matricaria) Flower/Leaf Extract, Ceramide NP, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Ormenis Multicaulis Oil, Sodium Hyaluronate, Citric Acid, Potassium Sorbate, Sodium Benzoate, Ethylhexylglycerin, Methylparaben, Butylparaben, Ethylparaben, Copper Tripeptide-1, Isobutylparaben, Propylparaben

Hair tonic

- Water, Butylene Glycol, Tocopheryl Acetate, PEG-60 Hydrogenated Castor Oil, Propylene Glycol, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Juice, Camellia Japonica Seed Oil, Allantoin, Sophora Angustifolia Root Extract, Citric Acid, Dipotassium Glycyrrhizate, Honey, Hydroxypropyl Chitosan, Panax Ginseng Root Extract, Morus Alba Bark Extract, Phenoxyethanol, Acorus Calamus Root Extract, Disodium EDTA, Polygonum Multiflorum Root Extract, Coix Lacryma-Jobi Ma-yuen Seed Extract, Algae Extract, Cnidium Officinale Root Extract, Paeonia Albiflora Root Extract, Capsicum Frutescens Fruit Extract, Potassium Sorbate, Sodium Benzoate, Ethylhexylglycerin, Methylparaben, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben

EH Hair Plus Regeneration Hair Care

INGREDIENTS AND APPEARANCE

EH HAIR PLUS REGENERATION HAIR CARE 
panthenol, niacinamide, menthol, salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70937-100

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70937-100-02	1 in 1 PACKAGE	08/26/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE	200 mL
Part 2	1 AMPULE	10 mL
Part 3	1 BOTTLE	120 mL

Part 1 of 3

EH HAIR PLUS HAIR COOL 
panthenol, niacinamide, menthol shampoo

Product Information
Item Code (Source)	NDC: 70937-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	1 g  in 200 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.6 g  in 200 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.4 g  in 200 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
AMMONIUM LAURYL SULFATE (UNII: Q7AO2R1M0B)
Sodium Lauroyl Glutamate (UNII: NCX1UU2D33)
Butylene Glycol (UNII: 3XUS85K0RA)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
Betaine (UNII: 3SCV180C9W)
Alcohol (UNII: 3K9958V90M)
Propylene Glycol (UNII: 6DC9Q167V3)
MORUS ALBA BARK (UNII: 7O71A48NDP)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
Sodium chloride (UNII: 451W47IQ8X)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
Ethylhexylglycerin (UNII: 147D247K3P)
Caprylyl Glycol (UNII: 00YIU5438U)
Allantoin (UNII: 344S277G0Z)
Arginine (UNII: 94ZLA3W45F)
Camellia Japonica Seed Oil (UNII: U37N0S910T)
CINNAMOMUM CAMPHORA LEAF (UNII: A0TKE4ZO0S)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
Honey (UNII: Y9H1V576FH)
ASIAN GINSENG (UNII: CUQ3A77YXI)
Trehalose (UNII: B8WCK70T7I)
Tropolone (UNII: 7L6DL16P1T)
ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
Phenoxyethanol (UNII: HIE492ZZ3T)
COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI)
Ceramide NP (UNII: 4370DF050B)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
METHYLPARABEN (UNII: A2I8C7HI9T)
Butylparaben (UNII: 3QPI1U3FV8)
Ethylparaben (UNII: 14255EXE39)
Isobutylparaben (UNII: 0QQJ25X58G)
Propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70937-101-02	1 in 1 PACKAGE
1	NDC: 70937-101-01	200 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/26/2016

Part 2 of 3

EH HAIR PLUS HAIR STICK AROMA AMPOULE 
panthenol liquid

Product Information
Item Code (Source)	NDC: 70937-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	0.15 g  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
Butylene Glycol (UNII: 3XUS85K0RA)
Betaine (UNII: 3SCV180C9W)
ALCOHOL (UNII: 3K9958V90M)
GINKGO (UNII: 19FUJ2C58T)
1,2-Hexanediol (UNII: TR046Y3K1G)
Propylene Glycol (UNII: 6DC9Q167V3)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
Honey (UNII: Y9H1V576FH)
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
PULSATILLA KOREANA ROOT (UNII: FY35I16MPL)
PURSLANE (UNII: M6S840WXG5)
Arginine (UNII: 94ZLA3W45F)
MENTHA ARVENSIS LEAF (UNII: A4IWO4DDZ9)
Phenoxyethanol (UNII: HIE492ZZ3T)
Allantoin (UNII: 344S277G0Z)
CINNAMOMUM CAMPHORA LEAF (UNII: A0TKE4ZO0S)
GRAPEFRUIT (UNII: O82C39RR8C)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ZANTHOXYLUM PIPERITUM FRUIT PULP (UNII: 7PFC2VA251)
ENGLISH WALNUT (UNII: 1V3SHR7QB7)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ASIAN GINSENG (UNII: CUQ3A77YXI)
FALLOPIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)
ANGELICA DAHURICA ROOT (UNII: 1V63N2S972)
COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI)
ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)
PEPPERMINT OIL (UNII: AV092KU4JH)
ANGELICA GIGAS ROOT (UNII: 32766B2FHX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)
Ceramide NP (UNII: 4370DF050B)
TEA TREE OIL (UNII: VIF565UC2G)
CLADANTHUS MIXTUS WHOLE (UNII: C7WCT2G709)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
Potassium Sorbate (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
Methylparaben (UNII: A2I8C7HI9T)
Butylparaben (UNII: 3QPI1U3FV8)
Ethylparaben (UNII: 14255EXE39)
PREZATIDE COPPER (UNII: 6BJQ43T1I9)
Isobutylparaben (UNII: 0QQJ25X58G)
Propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70937-102-02	3 in 1 PACKAGE
1	NDC: 70937-102-01	10 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/26/2016

Part 3 of 3

EH HAIR PLUS HAIR TONIC 
salicylic acid, niacinamide, panthenol, menthol liquid

Product Information
Item Code (Source)	NDC: 70937-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.6 g  in 120 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.36 g  in 120 mL
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	0.12 g  in 120 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	0.036 g  in 120 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)
Propylene Glycol (UNII: 6DC9Q167V3)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T)
Allantoin (UNII: 344S277G0Z)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
Honey (UNII: Y9H1V576FH)
ASIAN GINSENG (UNII: CUQ3A77YXI)
MORUS ALBA BARK (UNII: 7O71A48NDP)
Phenoxyethanol (UNII: HIE492ZZ3T)
ACORUS CALAMUS ROOT (UNII: XY1K7KIQ0F)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
FALLOPIA MULTIFLORA ROOT (UNII: AUZ3VD75MC)
COIX LACRYMA-JOBI VAR. MA-YUEN SEED (UNII: 8DW238I7ZI)
CNIDIUM OFFICINALE ROOT (UNII: 8S3OZD358J)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
TABASCO PEPPER (UNII: J1M3NA843L)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
Sodium Benzoate (UNII: OJ245FE5EU)
Ethylhexylglycerin (UNII: 147D247K3P)
Methylparaben (UNII: A2I8C7HI9T)
Butylparaben (UNII: 3QPI1U3FV8)
Ethylparaben (UNII: 14255EXE39)
Isobutylparaben (UNII: 0QQJ25X58G)
Propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70937-103-02	1 in 1 PACKAGE
1	NDC: 70937-103-01	120 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/26/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/25/2016

Labeler - ECOBIO Medical Institute, Inc. (689846753)

Registrant - ECOBIO Medical Institute, Inc. (689846753)

Establishment
Name	Address	ID/FEI	Business Operations
ECOBIO Medical Institute, Inc.		689846753	manufacture(70937-100)