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

5.5 Toner Mist

CELLADIX SKIN BALANCING PH 5.5 TONER MIST 
niacinamide, adenosine spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83490-603
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 mL
ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.04 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:83490-603-01120 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product05/24/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/24/2023
Labeler - 2359 US INC (118974080)
Registrant - 2359 US INC (118974080)
Establishment
NameAddressID/FEIBusiness Operations
isamogu Inc.695695834manufacture(83490-603)

Revised: 3/2023
Document Id: f6741dd0-0c4c-a06b-e053-2995a90ace85
Set id: f6741dd0-0c4b-a06b-e053-2995a90ace85
Version: 1
Effective Time: 20230309
 
2359 US INC