Label: HAND SANITIZER- alcohol gel

  • NDC Code(s): 77955-003-03
  • Packager: Custom Chemicial Solutions
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 22, 2024

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

View All Sections
  • Active ingredients (v/v)

    Ethyl Alcohol 70%

  • Purpose

    Antimicrobial

  • Uses:

    To decrease bacteria on the skin that could cause disease.

    Recommended for repeated use.

  • Warnings

    For external use only: hands

    Flammable. Keep away from fire or flame.

    When using this productavoid contact with eyes.

    In case of eye contact, flush eyes with water.

    Avoid contact with broken skin.

    Do not ingest or inhale.

    Stop use and ask a doctorif irritation or redness develops, or if condition persists for more than 72 hours.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    Pump enough product into palm of hand to thoroughly cover all surfaces of both hands.

    Rub hands together briskly until dry.

    For children under 6, use only under adult supervision

  • Other Information:

    Store below 110 F (43 C).

    May discolor some fabrics.

    May be harmful to wood finishes and plastics.

  • Inactive ingredients:

    Water (Eau), Triisopropanolamine, Propylene Glycol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Glycerin, Fragrance (Parfum), Isopropyl Myristate, Tocopheryl Acetate, Denatonium Benzoate.

  • PRINCIPAL DISPLAY PANEL

    HAND SANITIZER

    GEL

    Contains 70% Alcohol

    GENTLE ON HANDS

    500 MLS (16.9 US fl. oz)

    Manfactured for:

    Custom Chemical Solutions, LLC

    167 Commerce Drive

    Loveland, OH 45140

    container label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77955-003
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77955-003-03500 mL in 1 BOTTLE; Type 0: Not a Combination Product10/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)10/06/2020
    Labeler - Custom Chemicial Solutions (081096319)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company004236139manufacture(77955-003)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!