Label: ESIKA MEN CONTROL FRESH DEODORANT AND ANTIPERSPIRANT- aluminum chlorohydrate liquid

  • 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 December 4, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Aluminum chlorohydrate 4.5%

  • Purpose

    Antiperspirant

  • Uses

    • Reduces underarm perspiration.
    • All day protection.
  • Warnings

    For external use only

    Do not use on broken skin

    Ask a doctor before use if you have Kidney disease

    Stop use and ask a doctor if rash or irritation occurs

    When using this product

    • Keep away from face and mouth to avoid breathing it.
    • Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 deg. F.
    • Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

    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

    BUTANE, ISOBUTANE, PROPANE, CYCLOPENTASILOXANE, C12-15 ALKYL BENZOATE, DISTEARDIMONIUM HECTORITE, PARFUM (FRAGRANCE), ALUMINUM STARCH OCTENYLSUCCINATE, AQUA (WATER), TRICLOSAN, POLYVINYL ALCOHOL, CITRUS LIMON PEEL EXTRACT (CITRUS LIMON (LEMON) PEEL EXTRACT), CINNAMOMUN ZEYLANICUM BARK EXTRACT, LAVANDULA ANGUSTIFOLIA FLOWER EXTRACT (LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER EXTRACT), MENTHA PIPERITA LEAF EXTRACT(MENTHA PIPERITA (PEPPERMINT) LEAF EXTRACT), OLEA EUROPAEA LEAF EXTRACT (OLEA EUROPAEA (OLIVE) LEAF EXTRACT), ORIGANUM VULGARE LEAF EXTRACT, ROSMARINUS OFFICINALIS LEAF EXTRACT (ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT), HYDRASTIS CANADENSIS ROOT EXTRACT (HYDRASTIS CANADENSIS (GOLDENSEAL) ROOT EXTRACT), CYMBOPOGON CITRATUS EXTRACT, ACRYLATES / C12-22 ALKYL METHACRYLATE COPOLYMER, ZEA MAYS STARCH (ZEA MAYS (CORN) STARCH), HYDROLYZED CORN STARCH, HYDROLYZED CORN STARCH OCTENYLSUCCINATE, THYMUS VULGARIS EXTRACT (THYMUS VULGARIS (THYME) EXTRACT), MELALEUCA ALTERNIFOLIA LEAF (MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF).

  • SPL UNCLASSIFIED SECTION

    Dist. By Ventura Corporation, Ltd. San Juan,
    Puerto Rico 00926.

  • PRINCIPAL DISPLAY PANEL - 125 ml Bottle Label

    24h.
    DRY ACTION
    MEN
    Deodorant and antiperspirant
    all day protection

    Control Fresh

    0% Alcohol

    ésika

    125 ml e (4.2 fl.oz)

    PRINCIPAL DISPLAY PANEL - 125 ml Bottle Label
  • INGREDIENTS AND APPEARANCE
    ESIKA MEN CONTROL FRESH DEODORANT AND ANTIPERSPIRANT 
    aluminum chlorohydrate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-441
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Aluminum Chlorohydrate (UNII: HPN8MZW13M) (Aluminum Chlorohydrate - UNII:HPN8MZW13M) Aluminum Chlorohydrate0.045 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTANE (UNII: 6LV4FOR43R)  
    ISOBUTANE (UNII: BXR49TP611)  
    PROPANE (UNII: T75W9911L6)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    WATER (UNII: 059QF0KO0R)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    LEMON PEEL (UNII: 72O054U628)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    MENTHA PIPERITA LEAF (UNII: A389O33LX6)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    ROSEMARY (UNII: IJ67X351P9)  
    GOLDENSEAL (UNII: ZW3Z11D0JV)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    THYME (UNII: CW657OBU4N)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-441-01125 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35012/04/2012
    Labeler - Ventura Corporation LTD. (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-441)
    Establishment
    NameAddressID/FEIBusiness Operations
    Retycol S.A. (Colombia)880131693MANUFACTURE(13537-441)