Label: BODYCOLOGY TOASTED VANILLA SUGAR KIT- toasted vanilla sugar kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 August 5, 2012

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  • ACTIVE INGREDIENT

    image of hang tag

    Drug Facts

    Active ingredient Purpose

    Ethyl Alcohol 75% Antiseptic

    Uses To decrease bacteria on the skin.

    image of fragrance mist

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

    Stop use and consult doctorif irritation and redness develop and persist for more than 72 hours.

    Warnings

    For external use only.

    FLAMMABLE. Keep away from heat and flame.

    When using this product

    -Avoid contact with eyes. If contact occurs, flush eyes with water.

    -Avoid contact with broken skin.

    image of bodywash

    Directions

    -Wet hands with product.

    -Briskly rub hands together until dry.

    -For children under 6, use only under adult supervision.

    -Not recommended for infants.

    image of bottle

    Inactive ingredients: Water (Aqua, Eau), Fragrance (Parfum), Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Gelatin, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Ultramarines (CI 77007).

    May Contain: FD&C Red No. 4 (CI 14700), FD&C Yellow No. 5 (CI 19140), FD&C Blue No. 1 (CI 42090), D&C Red No. 33 (CI 17200).

  • PRINCIPAL DISPLAY PANEL

    image of body butter

    Bodycology

    Moisturiozing Hand Sanitizer

    with Aloe Vera

    kills 99% of bacteria without water

    30 mL 1 Fl Oz.

  • INGREDIENTS AND APPEARANCE
    BODYCOLOGY  TOASTED VANILLA SUGAR KIT
    toasted vanilla sugar kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51345-065
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51345-065-011 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 30 mL
    Part 21 BOTTLE 177 mL
    Part 31 BOTTLE 118 mL
    Part 41 BOTTLE 70 g
    Part 1 of 4
    BODYCOLOGY  TOASTED VANILLA SUGAR HAND SANITIZER
    ethyl alcohol gel
    Product Information
    Item Code (Source)NDC:51345-066
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL22.5 mL  in 22.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    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:51345-066-0130 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/30/2012
    Part 2 of 4
    BODYCOLOGY  FOAMING BODY WASH
    body and hand (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    INGRCOCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRHONEY (UNII: Y9H1V576FH)  
    INGRGLYCOL DISTEARATE (UNII: 13W7MDN21W)  
    INGRCOCO MONOETHANOLAMIDE (UNII: C80684146D)  
    INGRLAURETH-10 (UNII: BD7AST04GA)  
    INGRSODIUM CHLORIDE (UNII: 451W47IQ8X)  
    INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
    INGRSULISOBENZONE (UNII: 1W6L629B4K)  
    INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
    INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    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
    1177 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic06/30/2012
    Part 3 of 4
    BODYCOLOGY  FRAGRANCE MIST
    other fragrance preparations
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRALCOHOL (UNII: 3K9958V90M)  
    INGRWATER (UNII: 059QF0KO0R)  
    INGRALOE VERA LEAF (UNII: ZY81Z83H0X)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRSULISOBENZONE (UNII: 1W6L629B4K)  
    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
    1118 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic07/15/2012
    Part 4 of 4
    BODYCOLOGY  BODY BUTTER
    body and hand (excluding shaving preparations)
    Product Information
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRWATER (UNII: 059QF0KO0R)  
    INGRSOYBEAN OIL (UNII: 241ATL177A)  
    INGRGLYCERIN (UNII: PDC6A3C0OX)  
    INGRGLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
    INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRCOCOA BUTTER (UNII: 512OYT1CRR)  
    INGR.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    INGRTROLAMINE (UNII: 9O3K93S3TK)  
    INGRMETHYLPARABEN (UNII: A2I8C7HI9T)  
    INGRPROPYLPARABEN (UNII: Z8IX2SC1OH)  
    INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
    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
    170 g in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Cosmetic08/07/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/03/2012
    Labeler - Advanced Beauty Systems, Inc. (129986613)
    Registrant - Advanced Beauty Systems, Inc. (129998613)
    Establishment
    NameAddressID/FEIBusiness Operations
    Landy International545291775manufacture(51345-065, 51345-066)
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