Label: AHC HYDRATION SPECIAL GEN CREAM- adenosine cream

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 07/13

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • ACTIVE INGREDIENT

     Active Ingredients  Purpose
     Adenosine 0.04%  Skin Protectant 
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  • Uses

    Helps to improve skin moisture

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  • Warning

    For external use only

    do not use on damaged or broken skin

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  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a poison control right away.

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  • INSTRUCTIONS FOR USE

    Apply small amount to a clean skin and massage gently with fingertips.

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  • DOSAGE & ADMINISTRATION

    Dosage: Small Amount

    Administration: apply to a clean skin and massage gently

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  • Inactive Ingredients

    WATER
    1,3-BUTYLENE GLYCOL
    GLYCERIN
    DIPROPYLENE GLYCOL
    HYDROGENATED POLYDECENE (550 MW)
    CETYL ETHYLHEXANOATE
    DODECAMETHYLPENTASILOXANE
    MACADAMIA SEED OIL GLYCERETH-8 ESTERS
    CETOSTEARYL ALCOHOL
    ARACHIDYL ALCOHOL
    CYCLOMETHICONE
    POLYSORBATE 60
    LIMNANTHES ALBA WHOLE
    DIMETHICONE
    DOCOSANOL
    PANTHENOL
    ORYZA SATIVA WHOLE
    ARACHIDYL GLUCOSIDE
    SORBITAN SESQUIOLEATE
    PALMITIC ACID
    AVOCADO OIL
    OLIVE OIL
    STEARIC ACID
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
    PHENOXYETHANOL
    .ALPHA.-TOCOPHEROL ACETATE
    CHLORPHENESIN
    PHYLLOSTACHYS NIGRA SAP
    CAMELLIA SINENSIS WHOLE
    XANTHAN GUM
    ETHYLHEXYLGLYCERIN
    CAPRYLYL GLYCOL
    ALCOHOL
    .BETA.-BISABOLOL
    EDETIC ACID
    ZANTHOXYLUM PIPERITUM FRUIT PULP
    HYALURONATE SODIUM
    PANTOLACTONE, (+/-)-
    USNEA BARBATA
    PULSATILLA KOREANA WHOLE
    JASMINUM OFFICINALE FLOWER
    LECITHIN, SOYBEAN
    PULSATILLA KOREANA WHOLE
    HYDROGENATED CASTOR OIL
    PPG-26-BUTETH-26

    Fragnance

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    AHC HYDRATION SPECIAL GEN CREAM 
    adenosine cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:58930-028
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ADENOSINE (UNII: K72T3FS567) (ADENOSINE - UNII:K72T3FS567) ADENOSINE 20 mg  in 50 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    1,3-BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    DODECAMETHYLPENTASILOXANE (UNII: 0QDQ2VQ5YJ)  
    MACADAMIA SEED OIL GLYCERETH-8 ESTERS (UNII: C6734SM77O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    LIMNANTHES ALBA WHOLE (UNII: DKY81513ER)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHYLLOSTACHYS NIGRA SAP (UNII: 6Q89V97NS3)  
    CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALCOHOL (UNII: 3K9958V90M)  
    .BETA.-BISABOLOL (UNII: LP618AV2EA)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    ZANTHOXYLUM PIPERITUM FRUIT PULP (UNII: 7PFC2VA251)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PANTOLACTONE, (+/-)- (UNII: IID733HD2M)  
    USNEA BARBATA (UNII: D6DVA9TCAP)  
    PULSATILLA KOREANA WHOLE (UNII: 5R35881OBK)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    PPG-26-BUTETH-26 (UNII: 2II1K6TZ4P)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58930-028-01 1 in 1 CARTON
    1 50 mL in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 07/15/2013
    Labeler - Carver Korea Co.,Ltd (688442290)
    Registrant - Jemian USA Inc. (078822273)
    Establishment
    Name Address ID/FEI Business Operations
    Cosmecca Korea Co.,Ltd. 688830827 manufacture(58930-028)
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