Label: HAND SANITIZER- 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 April 3, 2020

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 62%

  • PURPOSE

    ANTISEPTIC

  • USES

    Helps reduce bacteria on the skin. Recommended for repeated use.

  • WARNINGS

    For external use only. Flammable. Keep away from fire or flame. When using this product avoid contact with eyes. In case of contact flush thoroughly with water. Avoid contact with open skin. Stop use and ask doctor if irritation or rash develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • DIRECTIONS

    Dispense enough product onto hands and rub together quickly until dry. Use as needed. Children under 6 years of age, use only under adult supervision.

  • INACTIVE INGREDIENTS

    Purified water, Propylene Glycol, Glycerin, Carbomer, Triethanolamine, Tocopherol Acetate, Coconut Oil, Aloe Vera gel, Fragrance

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Sunshine_Hand Sanitizer

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74598-111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL OR ALLYL SUCROSE CROSSLINKED) (UNII: K6MOM3T5YL)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74598-111-18238 mL in 1 BOTTLE; Type 0: Not a Combination Product04/03/2020
    2NDC:74598-111-14118 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package04/03/2020
    3NDC:74598-111-16476 mL in 1 BOTTLE; Type 0: Not a Combination Product04/03/2020
    4NDC:74598-111-113785 mL in 1 JUG; Type 0: Not a Combination Product04/03/2020
    5NDC:74598-111-1259 mL in 1 BOTTLE; Type 0: Not a Combination Product04/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/03/2020
    Labeler - Sunshine Tape Products LLC (080833035)
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