Label: HAND SANITIZER- 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 November 3, 2020

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  • SPL UNCLASSIFIED SECTION

    1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (77%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
    2. Glycerin
    3. Fragrance
    4. Sterile distilled water or boiled cold water.
    5. Acrylates/C10-30 Alkyl Acrylate Crosspolymer
    6. Butylene Glycol
    7. Aloe Barbadensis Leaf Juice
    8. Aminomethyl Propanol
    9. Titanium Dioxide
    10. 1,2-Hexanediol
    11. Agar
    12. Gellan Gum
    13. Calcium Alginate
    14. Ultramarines
    15. Phenoxyethanol
    16. Propylene Glycol
    17. Citric Acid
    18. Sodium Benzoate
    19. Potassium Sorbate

  • Active Ingredient(s)

    Alcohol 77% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • 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

    Stop use and ask a doctor if irritation and redness develops and persists.

  • 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

    1,2-Hexanediol, Acrylates /C10-30 Alkyl Acrylate Crosspolymer, Agar, Aloe Barbadensis Leaf Juice, Aminomethyl Propanol, Butylene Glycol, Calcium Alginate, Citric Acid, Fragrance (Parfum), Gellan Gum, Glycerin, Phenoxyethanol, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Titanium Dioxide (CI 77891), Ultramarines (CI 77007), Water (Aqua)

  • Package Label - Principal Display Panel

    50 mL NDC: 72686-184-05

    GARDENIA

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72686-184
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL77 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    AGAR, UNSPECIFIED (UNII: 89T13OHQ2B)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GELLAN GUM (LOW ACYL) (UNII: 7593U09I4D)  
    CALCIUM ALGINATE (UNII: 8P20S56HZI)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72686-184-0550 mL in 1 TUBE; Type 0: Not a Combination Product11/03/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/03/2020
    Labeler - Fareva Morton Grove, Inc. (116752326)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fareva Morton Grove, Inc.116752326manufacture(72686-184) , analysis(72686-184) , label(72686-184) , pack(72686-184) , relabel(72686-184) , repack(72686-184)
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