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 June 12, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the skin

  • Warnings

    For external use only. Flammable. Keep away from fire or flame.

    Do not use

    • on 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.

    Discontinue use if irritation or redness develops. If condition persists for more than 72 hours, consult a doctor.

    Keep out of reach of children.

    If swallowed, get medical help or call a poison control center immediately.

  • Directions

    • Place enough product in your palm to thoroughly cover your hands.
    • Rub hands together briskly until dry.
    • Children under 6 years of age should be supervised when using this product.
  • Other information

    • Store below 43°C (100°F)
    • May discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water, Glycerin, Hydroxyethylcellulose, Aloe Barbadensis Leaf Juice, Citric Acid, Sodium Hydroxide

  • Questions?

    678-897-4758

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Noble Roots LLC
    Lawrenceville, GA 30043

  • PRINCIPAL DISPLAY PANEL - 228 mL Bottle Label

    noble
    roots®

    Hand
    Sanitizer
    Infused with
    Moisturizing
    Aloe Vera

    8 oz (228 mL)

    PRINCIPAL DISPLAY PANEL - 228 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76577-010
    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
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Hydroxyethyl Cellulose, Unspecified (UNII: T4V6TWG28D)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76577-010-08228 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/01/2020
    2NDC:76577-010-803790 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart333A05/01/2020
    Labeler - Noble Roots, LLC (106744122)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pharmco Laboratories, Inc.096270814MANUFACTURE(76577-010)
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