Label: SKINTILLATE HAND SANITIZER- alcohol, isopropyl alcohol solution

  • 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 November 2, 2021

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  • Active Ingredients

    Alcohol (80%)
    Ethyl Alcohol (75%), Isopropyl Alcohol (5%)

  • ​Purpose

    Antiseptic skin cleanser

  • Use

    For personal hand hygiene to help prevent the spread of bacteria.

  • Warnings

    For external use only.

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. Stop use and consult a healthcare professional if irritation develops.

    Flammable. Keep away from heat and flame.

  • 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

    Adults and children over 2 years: For occasional and personal domestic use. Supervise children when they use this product. Spray onto hands and rub thoroughly for at least 30 seconds. Allow to dry.

  • Inactive ingredients

    Water, Hydrogen Peroxide , Glycerin, Hyaluronic Acid, Bergamot leaf oil, Lavender Flower Oil, Centella Asiatica Extract, Sodium pyruvate

    Other information
    Store at 68 0 to 70 0 F (20 0 to 25 0C). May discolor certain fabrics or surfaces.
    Questions? 1-844-800-6858

  • Package Label - Principal Display Panel

    Label 1

  • INGREDIENTS AND APPEARANCE
    SKINTILLATE HAND SANITIZER 
    alcohol, isopropyl alcohol solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75306-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    BERGAMOT OIL (UNII: 39W1PKE3JI)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    SODIUM PYRUVATE (UNII: POD38AIF08)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75306-003-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    2NDC:75306-003-0250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    3NDC:75306-003-0360 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    4NDC:75306-003-04100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    5NDC:75306-003-05120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    6NDC:75306-003-06160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    7NDC:75306-003-07200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    8NDC:75306-003-08250 mL in 1 BOTTLE, PLASTIC; 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 - D-Time Limited Liability Company (081728006)
    Establishment
    NameAddressID/FEIBusiness Operations
    D-Time Limited Liability Company081728006manufacture(75306-003)
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