Label: HYDRA BALANCING ROSE WATER- niacinamide, adenosine liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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.

Drug Label Information

Updated March 28, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    niacinamide, adenosine

  • PURPOSE

    anti wrinkle

    brightening

    calming

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • WARNINGS

    ■ For external use only.

    ■ Do not use in eyes.

    ■ lf swallowed, get medical help promptly.

    ■ Stop use, ask doctor lf irritation occurs.

    ■ Keep out of reach of children.

  • DOSAGE & ADMINISTRATION

    for external use only

  • INACTIVE INGREDIENT

    WATER
    METHYLPROPANEDIOL
    1,2-HEXANEDIOL
    NIACINAMIDE
    GLYCERIN
    BUTYLENE GLYCOL
    OCTYLDODECETH-16
    HYDROXYACETOPHENONE
    SODIUM CITRATE
    ROSA CENTIFOLIA FLOWER WATER
    CITRIC ACID
    ETHYLHEXYLGLYCERIN
    ADENOSINE
    FRAGRANCE
    DIOSCOREA JAPONICA ROOT EXTRACT
    PVM/MA COPOLYMER
    SODIUM POLYACRYLATE
    HYDROGENATED LECITHIN
    HYDROLYZED CORN STARCH
    PIPER METHYSTICUM LEAF/ROOT/STEM EXTRACT
    ARCTIUM LAPPA ROOT EXTRACT
    BETA-GLUCAN
    PHELLINUS LINTEUS EXTRACT
    XYLITYLGLUCOSIDE
    ANHYDROXYLITOL
    SUCROSE
    XYLITOL
    CENTELLA ASIATICA EXTRACT
    PENTYLENE GLYCOL
    PHENOXYETHANOL
    COLLAGEN
    GLUCOSE
    CAPRYLYL GLYCOL
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE
    TOCOPHEROL

    WATER
    METHYLPROPANEDIOL
    1,2-HEXANEDIOL
    NIACINAMIDE
    GLYCERIN
    BUTYLENE GLYCOL
    OCTYLDODECETH-16
    HYDROXYACETOPHENONE
    SODIUM CITRATE
    ROSA CENTIFOLIA FLOWER WATER
    CITRIC ACID
    ETHYLHEXYLGLYCERIN
    ADENOSINE
    FRAGRANCE
    DIOSCOREA JAPONICA ROOT EXTRACT
    PVM/MA COPOLYMER
    SODIUM POLYACRYLATE
    HYDROGENATED LECITHIN
    HYDROLYZED CORN STARCH
    PIPER METHYSTICUM LEAF/ROOT/STEM EXTRACT
    ARCTIUM LAPPA ROOT EXTRACT
    BETA-GLUCAN
    PHELLINUS LINTEUS EXTRACT
    XYLITYLGLUCOSIDE
    ANHYDROXYLITOL
    SUCROSE
    XYLITOL
    CENTELLA ASIATICA EXTRACT
    PENTYLENE GLYCOL
    PHENOXYETHANOL
    COLLAGEN
    GLUCOSE
    CAPRYLYL GLYCOL
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE
    TOCOPHEROL

  • INDICATIONS & USAGE

    apply proper amount to the skin

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HYDRA BALANCING ROSE WATER 
    niacinamide, adenosine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79593-0009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE0.044 g  in 100 mL
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79593-0009-1150 mL in 1 CONTAINER; Type 0: Not a Combination Product03/28/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/28/2021
    Labeler - DERMA CENTRIC INC (694952609)
    Registrant - DERMA CENTRIC INC (694952609)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(79593-0009)
    Establishment
    NameAddressID/FEIBusiness Operations
    DERMA CENTRIC INC694952609label(79593-0009)