Label: CLEANWELL NATURAL ORIGINAL HAND SANITIZER WIPES cloth

  • 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 3, 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.

  • WARNINGS

    For external use only

    Instruct children on proper use.

    Stop use and ask a doctor if skin becomes irritated

  • Directions:

    Apply thoroughly to hands and face as desired. Close lid between uses to retain moisture.  Do not flush wipes.  To Dispense:  Lift tab at front of lid to open.  Pull up corner of center sheet and thread through dispenser slit in lid.  Pull out exposed wipe at 45 angle and snap off.  The next wipe is ready for dispensing.

  • 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 Sanitizing Wipes Original.jpg

  • INGREDIENTS AND APPEARANCE
    CLEANWELL NATURAL ORIGINAL HAND SANITIZER WIPES 
    cleanwell natural original hand sanitizer wipes cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:28107-002
    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) 0.0005 kg  in 1 kg
    NERAL (UNII: 8M466BQL1X) 0.0018 kg  in 1 kg
    LEMON OIL (UNII: I9GRO824LL) 0.00075 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) 0.00008 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) 0.98651 kg  in 1 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:28107-002-090.16952 kg in 1 CANISTER; Type 0: Not a Combination Product06/15/2010
    2NDC:28107-002-080.04328 kg in 1 POUCH; Type 0: Not a Combination Product06/15/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35606/15/2010
    Labeler - CleanWell, LLC (079787350)
    Registrant - CleanWell, LLC (079787350)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tufco LP079862872manufacture(28107-002)
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