XOXO KIT BODYCOLOGY (ALCOHOL) KIT [ADVANCED BEAUTY SYSTEMS, INC.]

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XOXO KIT BODYCOLOGY (ALCOHOL) KIT [ADVANCED BEAUTY SYSTEMS, INC.]
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NDC 51345-117-01, 51345-118-01
Set ID 5e50033f-3212-49ce-9b55-ffae6999d1ba
Category HUMAN OTC DRUG LABEL
Packager Advanced Beauty Systems, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • ACTIVE INGREDIENT

    Active Ingredient Purpose

    Alcohol 75% Antiseptic

    Uses For hand washing to decrease bacteria on the skin

    Keep out of reach of children. In case of accidental ingestion, seek medical help or contact a Poison Control Center immediately.

    Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a doctor.

    Warnings

    For external use only

    Flammable. Keep away from flame or high heat.

    When using this product

    • Avoid contact with eyes. If contact occurs flush eyes with water.
    • Avoid contact with Broken skin

    Directions

    Wet hands thoroughly with product and allow to dry without wiping
    For children under 6, use only under adult supervision
    Not recommeded for infants

    v

    Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, Tocopheryl Acetate, Aloe Barbadensis Leaf juice, Ultra marines (CI 77007)

    May Contain: Red 4 (CI 14700), Yellow 5 (CI 19140), Blue 1 (CI 42090), Red 33 (CI 17200).

  • PRINCIPAL DISPLAY PANEL

    backer front

    backer back

    bodycology

    XOXO

    NET Wt 1 OZ / 30 g

    Moisturizing Body Cream

    1 FL OZ / 30 mL

    Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    XOXO KIT  BODYCOLOGY
    alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51345-117
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51345-117-011 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 30 mL
    Part 21 BOTTLE 30 g
    Part 1 of 2
    XOXO HAND SANITIZER 
    alcohol liquid
    Product Information
    Item Code (Source)NDC:51345-118
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GELATIN (UNII: 2G86QN327L)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51345-118-0130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/26/2013
    Part 2 of 2
    MOISTURIZING  
    body and hand (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSOYBEAN OIL (UNII: 241ATL177A)  
    INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
    INGRISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    INGRGLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRCOCOA BUTTER (UNII: 512OYT1CRR)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    INGRSODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRCARBOMER 940 (UNII: 4Q93RCW27E)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRTROLAMINE (UNII: 9O3K93S3TK)  
    INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    INGRSULISOBENZONE (UNII: 1W6L629B4K)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    INGRMETHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    INGRFD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    INGRFD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    INGRFD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    INGRD&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/26/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/26/2013
    Labeler - Advanced Beauty Systems, Inc. (129986613)
    Registrant - Advanced Beauty Systems, Inc. (129986613)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture(51345-117, 51345-118)
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