Label: LBEL DRY EFFECT 48 ANTIPERSPIRANT DEODORANT ROLL-ON- aluminum sesquichlorohydrate emulsion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 July 11, 2016

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Aluminum sesquichlorohydrate 18.00%

  • Purpose

    Antiperspirant

  • Uses

    • Reduces underarm perspiration
  • Warnings

    For external use only

    Do not use on broken skin

    Ask a doctor before use if you have Kidney desease

    Stop use and ask a doctor if rash or irritation occurs

    Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply to underarms only.
  • Inactive ingredients

    WATER, STEARETH-2, STEARETH-21, PPG-15 STEARYL ETHER, COCO-CAPRYLATE, DICAPRYLYL CARBONATE, FRAGRANCE, TRICLOSAN, POLYVINYL ALCOHOL, METHYLPARABEN, BISABOLOL, PROPYLENE CARBONATE, BENZALKONIUM CHLORIDE, PEG-20 CASTOR OIL, BHT, ACRYLATES/C12-22 ALKYL METHACRYLATE COPOLYMER, ALCOHOL DENAT., PROPYLENE GLYCOL, STEARALKONIUM HECTORITE, MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT, THYMUS VULGARIS (THYME) EXTRACT, HYDROLYZED SILK, TETRASODIUM EDTA, ORIGANUM VULGARE LEAF EXTRACT, ZEA MAYS (CORN) OIL, CALCIUM PANTOTHENATE, INOSITOL, RETINOL, ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT, ROSA MOSCHATA SEED OIL, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT, CINNAMOMUM ZEYLANICUM BARK EXTRACT, HYDRASTIS CANADENSIS (GOLDENSEAL) ROOT EXTRACT, OLEA EUROPAEA (OLIVE) LEAF EXTRACT, CITRUS LIMON (LEMON) PEEL EXTRACT, CYMBOPOGON CITRATUS EXTRACT, HYDROLYZED CORN STARCH, HYDROLYZED CORN STARCH OCTENYLSUCCINATE, MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF, ZEA MAYS (CORN) STARCH, BIOTIN, TOCOPHERYL ACETATE, HEXYL CINNAMAL, BUTYLPHENYL METHYLPROPIONAL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LINALOOL, ALPHA-ISOMETHYL IONONE, CITRONELLOL, COUMARIN.

  • SPL UNCLASSIFIED SECTION

    Dist. by Ventura Int Ltd. DBA Belcorp
    USA, Miami, FL 33126

  • PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

    antiperspirant deodorant
    roll on

    L'BEL
    dryeffect
    48

    50 ml e (1.7 fl.oz.)

    PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    LBEL DRY EFFECT 48 ANTIPERSPIRANT DEODORANT ROLL-ON 
    aluminum sesquichlorohydrate emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-955
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALUMINUM SESQUICHLOROHYDRATE (UNII: UCN889409V) (ALUMINUM SESQUICHLOROHYDRATE - UNII:UCN889409V) ALUMINUM SESQUICHLOROHYDRATE0.18 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    STEARETH-2 (UNII: V56DFE46J5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
    COCO-CAPRYLATE (UNII: 4828G836N6)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    THYME (UNII: CW657OBU4N)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    OREGANO (UNII: 0E5AT8T16U)  
    CORN OIL (UNII: 8470G57WFM)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    INOSITOL (UNII: 4L6452S749)  
    RETINOL (UNII: G2SH0XKK91)  
    ROSEMARY (UNII: IJ67X351P9)  
    ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    CINNAMON BARK OIL (UNII: XE54U569EC)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    LEMON PEEL (UNII: 72O054U628)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    BIOTIN (UNII: 6SO6U10H04)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    COUMARIN (UNII: A4VZ22K1WT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14783-955-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/05/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35007/05/2016
    Labeler - Ventura International LTD (603192787)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(14783-955)