EH PLUS H2CO3 COOL- panthenol, menthol kit

EH Plus H2CO3 Cool by

Drug Labeling and Warnings

EH Plus H2CO3 Cool 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

H2CO3 Cool Shampoo SB

Panthenol (0.5%)

Menthol (0.5%)

H2CO3 Cool Shampoo CA

Panthenol (0.5%)

Menthol (0.5%)

Purpose

Hair Tonic

Keep out of reach of children

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

Uses

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

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

Wet enough hair and scalp with warm water and massage evenly scalp with 3-5ml of water. Mix SB and CA shampoo 1:1 ratio, and put it on the palm. It makes foam, apply this on scalp and hair and massage gently. Rinse clean. (Wait for 2-3 minutes for more effective cleansing)

Inactive Ingredients

H2CO3 Cool Shampoo SB

Water, Disodium Cocoamphodiacetate, Sodium Chloride, Sodium Bicarbonate, Lauryl Hydroxysultaine, Olea Europaea (Olive) Fruit Oil, Mentha Piperita (Peppermint) Oil, Sodium Cocoyl Isethionate, Sodium Benzoate, Butylene Glycol, Lycium Chinense Fruit Extract, Decyl Glucoside, Lauryl Glucoside, Lysimachia Foenum-graecum Extract, Methylpropanediol, 1,2-Hexanediol, Cinnamomum Camphora (Camphor) Leaf Extract, Gastrodia Elata Root Extract, Phenoxyethanol, Ecklonia Cava Extract, Citrus Unshiu Peel Extract, Honey Extract, Hizikia Fusiforme Extract, Mangifera Indica (Mango) Leaf Extract, Caprylyl Glycol, Illicium Verum (Anise) Fruit Extract, Alcohol, Polyquaternium-10, Disodium EDTA

H2CO3 Cool Shampoo CA

Water, Disodium Cocoamphodiacetate, Sodium Chloride, Citric Acid, Lauryl Hydroxysultaine, Olea Europaea (Olive) Fruit Oil, Mentha Piperita (Peppermint) Oil, Sodium Benzoate, Butylene Glycol, Lycium Chinense Fruit Extract, Sodium Cocoyl Isethionate, Decyl Glucoside, Lauryl Glucoside, Lysimachia Foenum-graecum Extract, Methylpropanediol, 1,2-Hexanediol, Cinnamomum Camphora (Camphor) Leaf Extract, Gastrodia Elata Root Extract, Phenoxyethanol, Ecklonia Cava Extract, Citrus Unshiu Peel Extract, Honey Extract, Hizikia Fusiforme Extract, Mangifera Indica (Mango) Leaf Extract, Caprylyl Glycol, Illicium Verum (Anise) Fruit Extract, Alcohol, Polyquaternium-10, Disodium EDTA

EH Plus H2CO3 Cool Shampoo

INGREDIENTS AND APPEARANCE

EH PLUS H2CO3 COOL 
panthenol, menthol kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70937-104

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70937-104-02	1 in 1 PACKAGE	10/17/2016

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BOTTLE, DISPENSING	300 mL
Part 2	1 BOTTLE, DISPENSING	300 mL

Part 1 of 2

EH PLUS H2CO3 COOL SB 
panthenol, menthol shampoo

Product Information
Item Code (Source)	NDC: 70937-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	1.5 g  in 300 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.5 g  in 300 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
Sodium Chloride (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
LAURYL HYDROXYSULTAINE (UNII: 176KKP31OZ)
OLIVE OIL (UNII: 6UYK2W1W1E)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CINNAMOMUM CAMPHORA LEAF (UNII: A0TKE4ZO0S)
GASTRODIA ELATA TUBER (UNII: 08F85I5YAV)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ECKLONIA CAVA (UNII: UXX2N5V39P)
TANGERINE PEEL (UNII: JU3D414057)
HONEY (UNII: Y9H1V576FH)
SARGASSUM FUSIFORME (UNII: X436TJ4A11)
MANGIFERA INDICA LEAF (UNII: IK8VY4315G)
Caprylyl Glycol (UNII: 00YIU5438U)
STAR ANISE FRUIT (UNII: CK15HA8438)
Alcohol (UNII: 3K9958V90M)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70937-105-02	1 in 1 PACKAGE
1	NDC: 70937-105-01	300 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other

Part 2 of 2

EH PLUS H2CO3 COOL CA 
panthenol, menthol shampoo

Product Information
Item Code (Source)	NDC: 70937-106
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z)	PANTHENOL	1.5 g  in 300 mL
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.5 g  in 300 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
Sodium Chloride (UNII: 451W47IQ8X)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LAURYL HYDROXYSULTAINE (UNII: 176KKP31OZ)
OLIVE OIL (UNII: 6UYK2W1W1E)
PEPPERMINT OIL (UNII: AV092KU4JH)
SODIUM BENZOATE (UNII: OJ245FE5EU)
Butylene Glycol (UNII: 3XUS85K0RA)
LYCIUM CHINENSE FRUIT (UNII: TG711Q7A1Q)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
Methylpropanediol (UNII: N8F53B3R4R)
1,2-Hexanediol (UNII: TR046Y3K1G)
CINNAMOMUM CAMPHORA LEAF (UNII: A0TKE4ZO0S)
GASTRODIA ELATA TUBER (UNII: 08F85I5YAV)
Phenoxyethanol (UNII: HIE492ZZ3T)
ECKLONIA CAVA (UNII: UXX2N5V39P)
TANGERINE PEEL (UNII: JU3D414057)
HONEY (UNII: Y9H1V576FH)
SARGASSUM FUSIFORME (UNII: X436TJ4A11)
MANGIFERA INDICA LEAF (UNII: IK8VY4315G)
Caprylyl Glycol (UNII: 00YIU5438U)
STAR ANISE FRUIT (UNII: CK15HA8438)
Alcohol (UNII: 3K9958V90M)
POLYQUATERNIUM-10 (1000 MPA.S AT 2%) (UNII: GMR4PEN8PK)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70937-106-02	1 in 1 PACKAGE
1	NDC: 70937-106-01	300 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/17/2016

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(70937-104)