Label: HAND SANITIZER- isopropyl alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated December 13, 2022

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

View All Sections
  • Active Ingredient(s)

    Ethyl Alcohol 76% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic

  • Use

    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

  • Do not use

    • in children less than 2 months of age
    • on open skin wounds
  • 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 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.

  • STOP USE

    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

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

  • 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

    Ammonium polyacryloyldimethyl taurate, aqua/water/eau, argania spinosa (argan) kernel oil, benzoic acid, benzyl alcohol, C12-13 pareth-9, dehydroacetic acid, ethylhexylglycerin, hydroxypropyl guar, isopropyl myristate, isopropyl palmitate, lactic acid, palmitic acid, parfum/fragrance, phenoxyethanol, sodium hyaluronate.

  • Package Label - Principal Display Panel

    50 ml Box NDC: 69942-010-0550 ml Tube NDC: 69942-010-05

    50 ml NDC: 69942-010-05

    100 ml Box NDC: 69942-010-10

    100 ml Tube NDC: 69942-010-10

    100 ml NDC: 69942-010-10

    250 ml NDC: 69942-010-25

    250 ml NDC: 69942-010-25

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    isopropyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69942-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL76 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    C12-13 PARETH-9 (UNII: 9BXD858P37)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%) (UNII: 3A1I7376TC)  
    ARGANIA SPINOSA SEED (UNII: 8H7X7XB54H)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    WATER (UNII: 059QF0KO0R)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69942-010-051 in 1 BOX11/01/2021
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:69942-010-101 in 1 BOX11/01/2021
    2100 mL in 1 TUBE; Type 0: Not a Combination Product
    3NDC:69942-010-25250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other11/01/2021
    Labeler - Moroccanoil (964352202)
    Registrant - Moroccanoil (964352202)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fareva Morton Grove, Inc.116752326manufacture(69942-010)
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!