Label: CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER 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 April 4, 2018

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  • Active Ingredient:


    Thymus Vulgaris Oil (Thymol 0.05%)

  • Purpose

    Sanitizer

  • KEEP OUT OF REACH OF CHILDREN

  • Use:

    To sanitize hands

  • Warning:

    For external use only

    Instruct children on proper use.

    Stop use and ask a dotor if skin becomes irritated.

  • Directions:

    Spray until hands are wet and rub thoroughly until dry.

  • Inactive Ingredients:

    Aloe Barbadensis (Aloe) Leaf Juice*, Citric Acid, Citrus Aurantium Dulcis (Orange) Oil, Copper PCA*, Hydrolyzed Oats*, Origanum Vulgare (Oregano) Oil, Sodium Citrate, Sodium Coco Sulfate, Sodium Decylglucosides Hydroxypropyl Sulfonate, Vanilla Planifolia (Vanilla) Fruit Extract, Water

  • PRINCIPAL DISPLAY PANEL

    Natural Hand Sanitizer Spray.jpg

  • INGREDIENTS AND APPEARANCE
    CLEANWELL NATURAL ORANGE VANILLA HAND SANITIZER 
    cleanwell natural orange vanilla hand sanitizer spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28107-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    THYMOL (UNII: 3J50XA376E) (THYMOL - UNII:3J50XA376E) THYMOL0.0005 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    THYME OIL (UNII: 2UK410MY6B) 0.0003 kg  in 1 kg
    OREGANO LEAF OIL (UNII: 7D0CGR40U1) 0.0001 kg  in 1 kg
    ORANGE OIL (UNII: AKN3KSD11B) 0.0019 kg  in 1 kg
    DECANAL (UNII: 31Z90Q7KQJ) 0.00015 kg  in 1 kg
    VANILLA PLANIFOLIA OIL (UNII: 0A3F415158) 0.002 kg  in 1 kg
    SODIUM DECYLGLUCOSIDES HYDROXYPROPYLSULFONATE (UNII: 55P9UXJ9C3) 0.0016 kg  in 1 kg
    SODIUM COCO-SULFATE (UNII: 3599J29ANH) 0.0032 kg  in 1 kg
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) 0.00046 kg  in 1 kg
    SODIUM CITRATE (UNII: 1Q73Q2JULR) 0.0007 kg  in 1 kg
    COPPER (UNII: 789U1901C5) 0.0008 kg  in 1 kg
    AMINO ACIDS, OAT (UNII: NU3FAK86IP) 0.001 kg  in 1 kg
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.0025 kg  in 1 kg
    WATER (UNII: 059QF0KO0R) 0.98525 kg  in 1 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:28107-008-020.03 kg in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/01/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35611/01/2007
    Labeler - CleanWell, LLC (079787350)
    Registrant - CleanWell, LLC (079787350)
    Establishment
    NameAddressID/FEIBusiness Operations
    Precise Packaging LLC079904428manufacture(28107-008)
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