Label: RAINBOW HAND SANITIZER CLEAR- ethyl alcohol liquid

  • 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 1, 2021

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 68% 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, Mugwort Extract, Calendula Officinalis Flower,Camellia Sinensis Leaf Extract, Mulberry Root Extract, Licorice Extract,Rosmarinus Officinalis (Rosemary) Leaf Oil, Polysorbate 20, Fragrance

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    RAINBOW HAND SANITIZER CLEAR 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75063-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL68 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARTEMISIA PRINCEPS LEAF (UNII: SY077EW02G)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    MORUS ALBA ROOT (UNII: CST1G9BZGD)  
    LICORICE (UNII: 61ZBX54883)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75063-0004-11 in 1 BOX09/20/2021
    140 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 finalpart333A09/20/2021
    Labeler - Belleson Inc (694793004)
    Establishment
    NameAddressID/FEIBusiness Operations
    Belleson Inc694793004manufacture(75063-0004)
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