DUAL TREATMENT - COLD SORE THERAPY AND DAILY LIP MAINTENANCE (CAMPHOR, ALLANTOIN) KIT [NERIUM SKINCARE, INC.]

DUAL TREATMENT - COLD SORE THERAPY AND DAILY LIP MAINTENANCE (CAMPHOR, ALLANTOIN) KIT [NERIUM SKINCARE, INC.]
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NDC 72216-212-22
Set ID 2fd37f9f-c4df-4cb5-9c31-3b22974f5748
Category HUMAN OTC DRUG LABEL
Packager Nerium SkinCare, Inc.
Generic Name
Product Class
Product Number
Application Number PART
  • ACTIVE INGREDIENT

    COLD SORE THERAPY:

        CAMPHOR 2%

    DAILY LIP MAINTENANCE:

        ALLANTOIN 0.5%

  • PURPOSE

    COLD SORE THERAPY:

        FEVER BLISTER/COLD SORE TREATMENT

    DAILY LIP MAINTENANCE:

        LIP PROTECTANT

  • USE

    COLD SORE THERAPY:

    • For the temporary relief of pain and itching associated with cold sores.

    DAILY LIP MAINTENANCE:

    • Helps protect chapped lips

  • WARNINGS

    COLD SORE THERAPY:

    For external use only.
    Avoid contact with the eyes.
    If condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician.

    If swallowed, get medical help or contact a Poison Control Center right away.

    DAILY LIP MAINTENANCE:

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    COLD SORE THERAPY:

    • Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a physician.

    DAILY LIP MAINTENANCE:

    • For adults use: apply daily as needed.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • INACTIVE INGREDIENTS

    COLD SORE THERAPY:

    Aloe Barbadensis Leaf Juice, Nerium Oleander Leaf Extract (NAE-8®), Docosanol, Cocos Nucifera Oil, Glycerin, Arachidyl Alcohol, Cetearyl Olivate, Hydrolyzed Egg Shell Membrane (BiovaDerm®), Olea Europaea Fruit Oil, Water, Sorbitan Olivate, Sucrose Cocoate, Dimethicone, Linum Usitatissimum Seed Oil, Tocopherol, Arachidyl Glucoside, Pelargonium Graveolens (Geranium) Flower Oil, Allantoin, Leuconostoc/ Radish Root Ferment Filtrate, Xanthan Gum, Potassium Sorbate, Carrageenan, Benzyl Alcohol, Ascorbyl Palmitate,
    Dipotassium Glycyrrhizate, Lysine HCL, Olea Europaea (Olive) Leaf Extract.

    DAILY LIP MAINTENANCE:

    Aloe Barbadensis Leaf Juice, Glycerin, Propanediol, Nerium Oleander Leaf Extract (NAE-8®), Ethylhexyl Methoxycinnamate, Hydrolyzed Egg Shell Membrane (BiovaDerm®), Water (Aqua), Glyceryl Caprylate, Hydroxyethylcellulose, Glyceryl Stearate, Caprylic/Capric Triglyceride, Linum Usitatissimum (Linseed) Seed Oil, Carrageenan, Lysolecithin, Sclerotium Gum, Pelargonium Graveolens Flower
    Oil, Leuconostoc/Radish Root Ferment Filtrate, Benzyl Alcohol, Pullulan, Xanthan Gum, Glyceryl Undecylenate, Potassium Sorbate, Butter Extract, Cocos Nucifera (Coconut) Fruit Extract, Cucumis Melo Cantalupensis Fruit Extract, Musa Sapientum (Banana) Fruit Extract, Pimpinella Anisum (Anise) Fruit Extract, Prunus Armeniaca (Apricot) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Santalum Album (Sandalwood ) Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Vanilla Planifolia Fruit Extract

  • QUESTIONS?

    1-(844)-599-7787 (9 am to 5 pm CST)

  • PRINCIPAL DISPLAY PANEL

    Dual Treatment Kit_UC

  • INGREDIENTS AND APPEARANCE
    DUAL TREATMENT - COLD SORE THERAPY AND DAILY LIP MAINTENANCE 
    camphor, allantoin kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72216-212
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72216-212-221 in 1 BOX05/18/2018
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 1
    Part 2
    Part 1 of 2
    COLD SORE THERAPY 
    camphor cream
    Product Information
    Item Code (Source)NDC:72216-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    NERIUM OLEANDER LEAF (UNII: 7KV510R6H6)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    EGG SHELL MEMBRANE (UNII: N7QBR4212V)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    SUCROSE COCOATE (UNII: 3H18P0UK73)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    ALLANTOIN (UNII: 344S277G0Z)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/18/2018
    Part 2 of 2
    DAILY LIP MAINTENANCE 
    allantoin cream
    Product Information
    Item Code (Source)NDC:72216-103
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALLANTOIN (UNII: 344S277G0Z) (ALLANTOIN - UNII:344S277G0Z) ALLANTOIN0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    NERIUM OLEANDER LEAF (UNII: 7KV510R6H6)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    EGG SHELL MEMBRANE (UNII: N7QBR4212V)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LINSEED OIL (UNII: 84XB4DV00W)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    BETASIZOFIRAN (UNII: 2X51AD1X3T)  
    PELARGONIUM GRAVEOLENS FLOWER OIL (UNII: 3K0J1S7QGC)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BUTTER (UNII: 3B7C0987O9)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CUCUMIS MELO VAR. CANTALUPENSIS WHOLE (UNII: HUU66O04OX)  
    BANANA (UNII: 4AJZ4765R9)  
    ANISE (UNII: 21C2F5E8RE)  
    APRICOT (UNII: 269CJD5GZ9)  
    APPLE (UNII: B423VGH5S9)  
    SANDALWOOD (UNII: 3641YW25N2)  
    CRANBERRY (UNII: 0MVO31Q3QS)  
    VANILLA (UNII: Q74T35078H)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/21/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart05/18/2018
    Labeler - Nerium SkinCare, Inc. (859420916)

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