Label: ESIKA TOTAL SEC DELICATE SKIN ALCOHOL FREE WOMENS DEODORANT AND ANTIPERSPIRANT - ALL DAY PROTECTION- aluminum chlorohydrate spray

  • 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 June 3, 2013

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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 desease

    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, ALUMINUM STARCH OCTENYLSUCCINATE, PARFUM (FRAGRANCE), BISABOLOL, TRICLOSAN, PROPYLENE GLYCOL, AQUA (WATER), BAMBUSA ARUNDINACEA LEAF EXTRACT

  • SPL UNCLASSIFIED SECTION

    P.R.: Distributed by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926.

  • PRINCIPAL DISPLAY PANEL - 125 mL Bottle Label

    ésika

    total
    sec

    DELICATE SKIN

    Alcohol Free
    Women's
    Deodorant and
    Antiperspirant
    All day protection

    24
    hours

    125 ml e (4.2 fl.oz.)

    Principal Display Panel - 125 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    ESIKA   TOTAL SEC DELICATE SKIN ALCOHOL FREE WOMENS DEODORANT AND ANTIPERSPIRANT - ALL DAY PROTECTION
    aluminum chlorohydrate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-505
    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)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TRICLOSAN (UNII: 4NM5039Y5X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    BAMBUSA BAMBOS LEAF (UNII: HW86D1FGSS)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-505-01125 mL in 1 BOTTLE, SPRAY
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35005/27/2013
    Labeler - Ventura Corporation LTD. (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Retycol S.A. (Colombia)880131693MANUFACTURE(13537-505)