Label: RAINBOW HAND SANITIZER GREEN- ethyl 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 October 22, 2021

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Uses

    Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and
    water are not available. Warnings For external use only, Flammable. Keep away from heat or flame

  • Warnings

    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. 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.

  • KEEP OUT OF REACH OF CHILDREN

  • Directions

    • Place enough product on hands to cover all surfaces. Rub hands together until dry.
    • Supervise children under 6 years of age when using this product to avoid swallowing.

  • Other information

    • Store between 15-30C (59-86F)

    • Avoid freezing and excessive heat above 40C (104F)

  • Inactive ingredients

    Aqua, Glycerin, Aloe vera leaf , Carbomer, Triethanolamine, Mugwort extract, Calendula officinalis flower, Camellia Sinensis Leaf Extract, Mulberry root extract, Licorice extract, Rosmarinus officinalis (Rosmary) leaf oil, Polysorbate 20, Fragrance, FD&C Blue No. 1, FD&C Yellow No. 5

  • Product label

    image description

  • INGREDIENTS AND APPEARANCE
    RAINBOW HAND SANITIZER GREEN 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75063-0012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    MORUS ALBA ROOT (UNII: CST1G9BZGD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CAMELLIA SINENSIS ROOT (UNII: 8H54O0V2K3)  
    LICORICE (UNII: 61ZBX54883)  
    ROSEMARY (UNII: IJ67X351P9)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75063-0012-1500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product10/20/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/20/2021
    Labeler - Belleson Inc (694793004)
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