Label: ECLADO ANTISEPTIC MOISTURE- alcohol spray

  • 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 May 6, 2020

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  • ACTIVE INGREDIENT

    Active ingredients: 60%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water, Glycerin, Sodium Citrate, Glycereth-25 PCA Isostearate, Mentha Piperita (Peppermint) Oil, Lavandula Hybrida Herb Oil, Melaleuca Alternifolia (Tea Tree) Leaf Oil

  • PURPOSE

    Purpose: ANTISEPTIC

  • WARNINGS

    Warnings:

    For external use only. Flammable. Keep away from heat or flame
    --------------------------------------------------------------------------------------------------------
    Do not use
    • in children less than 2 months of age
    • on open skin wounds
    --------------------------------------------------------------------------------------------------------
    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
    --------------------------------------------------------------------------------------------------------
    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

  • KEEP OUT OF REACH OF CHILDREN

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

  • Uses

    Uses:

    Hand and body antiseptic intended for preventing infectious diseases.

  • Directions

    Directions:

    • Spay enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other Information

    Other Information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat above 40C (104F)

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    ECLADO ANTISEPTIC MOISTURE 
    alcohol spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76900-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL102 mL  in 170 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Sodium Citrate (UNII: 1Q73Q2JULR)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76900-010-021 in 1 CARTON05/01/2020
    1NDC:76900-010-01170 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/01/2020
    Labeler - Laon Cosmetic (689201314)
    Registrant - Laon Cosmetic (689201314)
    Establishment
    NameAddressID/FEIBusiness Operations
    DASOL CO.,LTD.557839013manufacture(76900-010)
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