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 April 29, 2020

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  • SPL UNCLASSIFIED SECTION

    Hand Sanitizer with NDC 00000-000 is a a human over the counter drug product labeled by NTML Group Ltd. The generic name of Hand Sanitizer is alcohol. The product's dosage form is gel and is administered via topical form.

  • Active Ingredient(s)

    Alcohol 70% v/v. Purpose: Antiseptic

  • Purpose

    Antiseptic, Hand Sanitizer

  • Use

    For handwashing to decrease bacteria on the skin

    Recommended for repeated use

  • Warnings

    For external use only

    Flammable, keep away from fire and flame

    Do not drink

    If taken internally will produce serious gastric disturbances

  • Do not use

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

    When using this product avoid the eyes and mucous membrane

    In the case of eyes or mucous membranes contact, rinse area thoroughly with water

  • STOP USE

    Stop use and ask a doctor if condition worsens, redness or irritation develops

    If condition persists for more than 3 days

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed contact a doctor or Poison Control Center immediately.

  • Directions

    Rub dime sized amount between hands until dry

    Supervise children in the use of this product

    In the case of eye contact, rinse eyes thoroughly with water

  • Other information

    Store below 105 F

    May discolour some fabrics

  • Inactive ingredients

    Aminomethyl Propanol, Carbomer, Glycerin, Propylene Glycol, Water.

  • Package Label - Principal Display Panel

    70% Alcohol Gel

    30 mL (1 fl oz) 30 ml label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77366-001
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77366-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product05/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - NTML Group Ltd (664159445)
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