Label: CREAMOL HAND SANITIZER WIPE- alcohol swab

  • 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 September 7, 2020

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  • ACTIVE INGREDIENT

    Ethanol alcohol 80%. (w/w) Purpose: Antimicrobial

  • PURPOSE

    Antiseptic, Hand Sanitizer

  • INDICATIONS & USAGE

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available. Wipe hands; discard.

  • WARNINGS

    For external use only. Flammable. Keep away from heat or flame

  • DO NOT USE

    Do not use,

    • in children less than 2 months of age
    • on open skin wounds
  • WHEN USING

    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. If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    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.

  • Directions

    Wipe hands and dischard.

  • Other information

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

    glycerin, Hypericum perforatum, Melaleuca alternifolia, water, parfum

  • PRINCIPAL DISPLAY PANEL

    NDC: 77892-0009-1 innerNDC: 77892-0009-1 outerNDC: 77892-0009-1 inner

  • INGREDIENTS AND APPEARANCE
    CREAMOL HAND SANITIZER WIPE 
    alcohol swab
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77892-0009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77892-0009-14 g in 1 POUCH; Type 0: Not a Combination Product09/07/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/03/2020
    Labeler - LABER KIMYA AR-GE SANAYI TICARET - LEVENT KAHRIMAN (502952094)
    Establishment
    NameAddressID/FEIBusiness Operations
    LABER KIMYA AR-GE SANAYI TICARET - LEVENT KAHRIMAN502952094manufacture(77892-0009)
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