Label: CREME21 KIT PACK- alcohol kit

  • NDC Code(s): 73797-120-20, 73797-121-21, 73797-122-22
  • Packager: Creme 21 GmbH
  • 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 August 3, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    ALCOHOL 70% v/v......... antimicrobial

  • ASK DOCTOR

    Stop use and ask doctor if irritation or rash occurs. These may be signs of serious condition.

  • DO NOT USE

    Do not use

    In children less than 2 months of age

    On open skin wounds

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of children. If swallowed, get medical help or contact a poison control centre right away.

  • 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

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of serious condition.

  • OTHER SAFETY INFORMATION

    ​Store between 15 to 30°C (59 to 86° F), Avoid freezing and excessive heat above 40°C (104° F)

  • WARNINGS

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

  • INACTIVE INGREDIENT

    Creme 21 antibacterial sanitizer-Aqua (water), Aloe barbadensis leaf juice, Aminomethyl propanol, Caprylyl glycol,Glycerin, Isopropyl alcohol, Isopropyl myristate,Tocopheryl acetate.

    Creme 21 hand sanitizer germ protection with aloe vera and glycerin-Aqua (water), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Caprylyl Glycol, Fragrance, Glycerin, Isopropyl alcohol, Isopropyl Myristate, Tocopheryl acetate.

  • INSTRUCTIONS FOR USE

    Place enough products on hands to cover all surfaces. Rubs hands together until dry.

    Supervise children under 6 years of age when using this products to avoid swallowing.

  • PURPOSE

    USES: Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.

  • INDICATIONS & USAGE

    USES: Hand sanitizer to help reduce bacteria that potentially cause disease. For use when soap and water are not available.

  • DOSAGE & ADMINISTRATION

    Place enough products on hands to cover all surfaces. Rubs hands together until dry.

    Supervise children under 6 years of age when using this products to avoid swallowing.

  • PRINCIPAL DISPLAY PANEL

    creme 21 kit pack

  • INGREDIENTS AND APPEARANCE
    CREME21 KIT PACK 
    alcohol kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73797-120
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73797-120-201 in 1 KIT08/01/2020
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 10 BOTTLE, SPRAY 1 mL
    Part 20 BOTTLE, PLASTIC 1 mL
    Part 1 of 2
    CREME 21 ANTIBACTERIAL SANITIZER 
    alcohol spray
    Product Information
    Item Code (Source)NDC:73797-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL7 mL  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73797-121-2171 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/03/2020
    Part 2 of 2
    CREME 21 HAND SANITIZER GERM PROTECTION WITH ALOE VERA AND GLYCERIN 
    alcohol gel
    Product Information
    Item Code (Source)NDC:73797-122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL7 mL  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    (C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73797-122-2281 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/01/2020
    Labeler - Creme 21 GmbH (315190250)
    Registrant - Creme 21 GmbH (315190250)