Label: CREME 21 HAND SANITIZER GERM PROTECTION WITH ALOE VERA AND GLYCERIN- alcohol gel

  • NDC Code(s): 73797-103-07, 73797-103-08, 73797-103-09, 73797-103-10
  • 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 May 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

    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 hand sanitizer germ protection with aloevera and glycerin

  • INGREDIENTS AND APPEARANCE
    CREME 21 HAND SANITIZER GERM PROTECTION WITH ALOE VERA AND GLYCERIN 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73797-103
    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
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 132584PQMO)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73797-103-0760 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2020
    2NDC:73797-103-08118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2020
    3NDC:73797-103-09240 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2020
    4NDC:73797-103-10480 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/03/2020
    Labeler - Creme 21 GmbH (315190250)
    Registrant - Creme 21 GmbH (315190250)
    Establishment
    NameAddressID/FEIBusiness Operations
    RNA PHARMA, LLC079103999manufacture(73797-103)