Label: PARALAPIEL CLINIC SANITIZER- alcohol gel

  • 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 13, 2020

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  • ACTIVE INGREDIENT

    Alcohol

  • INACTIVE INGREDIENT

    Water, Glycerin, Honey extract, Carthamus tinctorius (Safflower) flower extract, Rosa damascena flower extract, Chrysanthemum indicum flower extract, Calendula officinalis flower extract, Oenothera biennis (Evening primrose) flower extract, Nelumbo nucifera flower extract, Lavandula angustifolia (Lavender) flower extract, Inula britannica flower extract, Lonicera japonica (Honeysuckle) flower extract, Aloe barbadensis leaf juice, Sodium hyaluronate, Potassium hydroxide, Carbomer, Butylene glycol, Fragrance

  • PURPOSE

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF THE CHILDREN

  • INDICATIONS & USAGE

    Handling : Use normal good handling procedures.

    Storage : Keep containers tightly closed, away from heat and light and store at a cool and dry place.

  • WARNINGS

    For external use only. Flammable, Keep away from fire or flames.
    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.
    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.

  • DOSAGE & ADMINISTRATION

    Apply a proper amount on your hand and rub hands palm to palm, then backs of fingers to opposing palms with interlaced fingers.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    PARALAPIEL CLINIC SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77499-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL37.2 mL  in 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE (UNII: V5VD430YW9)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77499-0001-160 mL in 1 TUBE; Type 0: Not a Combination Product05/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2020
    Labeler - Charming Cosmetics. Co. Ltd (689935740)
    Registrant - Charming Cosmetics. Co. Ltd (689935740)
    Establishment
    NameAddressID/FEIBusiness Operations
    Charming Cosmetics. Co. Ltd689935740manufacture(77499-0001)
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