83490-603 Celladix Skin Balancing pH 5.5 Toner Mist

Celladix Skin Balancing pH 5.5 Toner Mist by

Drug Labeling and Warnings

Celladix Skin Balancing pH 5.5 Toner Mist by is a Otc medication manufactured, distributed, or labeled by 2359 US INC, isamogu Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

CELLADIX SKIN BALANCING PH 5.5 TONER MIST- niacinamide, adenosine spray 
2359 US INC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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83490-603 Celladix Skin Balancing pH 5.5 Toner Mist

Active Ingredients

Niacinamide 2.0%
Adenosine 0.04%

Purposes

Niacinamide 2.0%-------Skin protectant
Adenosine 0.04%----- Astringent

Uses

For skin barrier repair, perfect for oily skin.

Warnings

For external use only.

Warnings

Do not use it on open wounds and sensitive skin.

Warnings

Keep out of reach of children.

Warnings

Stop use and ask a doctor If there are any abnormal symptoms or side effects such as red spots, swelling, or itching during or immediately after use.

Warnings

Directions

Spray an appropriate amount of the mist and gently spread it over the skin.

Inactive Ingredients

Water, Diglycerin, Propanediol, Methylpropanediol, Glycerin, Niacinamide, 1,2-Hexanediol, Polyglyceryl-10 Laurate, Sodium Citrate, Butylene Glycol, Dipotassium Glycyrrhizate, Ethylhexylglycerin, Adenosine, Citric Acid, Disodium EDTA, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Eucalyptus Globulus Leaf Extract, Coriandrum Sativum (Coriander) Extract, Laurus Nobilis Leaf Extract, Cinnamomum Cassia Bark Extract, Machilus Thunbergii Branch Extract, Caprylic/Capric Triglyceride, Lavandula Hybrida Oil, Phosphatidylcholine, Polyglutamic Acid, Lavandula Angustifolia (Lavender) Oil, Ceramide NP, Sodium Hyaluronate, Pentylene Glycol, Laminaria Japonica Extract, Ulmus Davidiana Root Extract, Viola Mandshurica Flower Extract, Dioscorea Japonica Root Extract, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Hydrogenated Lecithin, Hydroxypropyltrimonium Hyaluronate, Glycine, Phytosterols, Serine, Glutamic Acid, Alanine, Lysine, Hydrolyzed Hyaluronic Acid, Sodium Acetylated Hyaluronate, Proline, Arginine, Threonine, Palmitic Acid, Stearic Acid, Sodium Hyaluronate Crosspolymer, Hydrolyzed Sodium Hyaluronate., Hyaluronic Acid, Potassium Hyaluronate, Myristic Acid

Label

CELLADIX SKIN BALANCING PH 5.5 TONER MIST 
niacinamide, adenosine spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83490-603
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	2 g  in 100 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567)	ADENOSINE	0.04 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
LAVANDIN OIL (UNII: 9RES347CKG)
GLUTAMIC ACID (UNII: 3KX376GY7L)
LYSINE (UNII: K3Z4F929H6)
ARGININE (UNII: 94ZLA3W45F)
HYALURONIC ACID (UNII: S270N0TRQY)
MYRISTIC ACID (UNII: 0I3V7S25AW)
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)
CHINESE CINNAMON (UNII: WS4CQ062KM)
DIGLYCERIN (UNII: 3YC120743U)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
DIOSCOREA JAPONICA ROOT (UNII: I43FCF3356)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCINE (UNII: TE7660XO1C)
SERINE (UNII: 452VLY9402)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
BAY LEAF (UNII: WS0Y3M85RF)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ORANGE OIL (UNII: AKN3KSD11B)
CORIANDRUM SATIVUM WHOLE (UNII: 740M8BF6EF)
MACHILUS THUNBERGII BRANCH (UNII: 301F5K1I0R)
ALANINE (UNII: OF5P57N2ZX)
PROLINE (UNII: 9DLQ4CIU6V)
CERAMIDE NP (UNII: 4370DF050B)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
ULMUS DAVIDIANA ROOT (UNII: URQ79U8261)
VIOLA MANDSHURICA FLOWER (UNII: 46MR945M6X)
WATER (UNII: 059QF0KO0R)
LAMINARIA JAPONICA (UNII: WE98HW412B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
STEARIC ACID (UNII: 4ELV7Z65AP)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
LAVENDER OIL (UNII: ZBP1YXW0H8)
THREONINE (UNII: 2ZD004190S)
BERGAMOT OIL (UNII: 39W1PKE3JI)
EUCALYPTUS GLOBULUS LEAF (UNII: S546YLW6E6)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
PALMITIC ACID (UNII: 2V16EO95H1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83490-603-01	120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	05/24/2023	07/29/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/24/2023	07/29/2024

Labeler - 2359 US INC (118974080)

Registrant - 2359 US INC (118974080)

Establishment
Name	Address	ID/FEI	Business Operations
isamogu Inc.		695695834	manufacture(83490-603)

Revised: 7/2024

Document Id: 1e63ccf4-cc2a-7228-e063-6394a90a3615

34390-5

Set id: f6741dd0-0c4b-a06b-e053-2995a90ace85

Version: 2

Effective Time: 20240729