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 5, 2020

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  • Drug Facts

  • Active ingredients

    Ethyl Alcohol 70% v/v

    Purposes

    Antimicrobial

  • Uses

    • Help reduce bacteria, which could cause disease
    • Recommended for repeated use
  • Warnings

    Flammable. Keep away from fire or flame.

    For External Use Only.

    When using this product,

    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

    Stop use & ask a doctor if

    if irritation or redness develops and persists.

    Keep out of reach of children.

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

  • Directions

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

    • Store below 86°F(30°C)
  • Inactive ingredients

    Carbopol, Glycerin, Licorice Extract, Neem Extract, Propylene glicol, Triethanolamine, Water.

  • Question or comments?

    +1(956) 612-8408

  • Package Labeling :250ml (Bag)

    Bottle250ml

  • Package Labeling :250ml(Bottle)

    Bottle 250ml

  • Package Labeling :1L

    Bottle 1L

  • Package Labeling :30ml

    Bottle 30ml

  • Package Labeling :500ml

    Bottle500ml

  • Package Labeling :60ml

    Bottle60ml

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78659-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LICORICE (UNII: 61ZBX54883)  
    AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78659-000-01250 mL in 1 BAG; Type 0: Not a Combination Product05/04/2020
    2NDC:78659-000-02250 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
    3NDC:78659-000-031000 mL in 1 BAG; Type 0: Not a Combination Product05/04/2020
    4NDC:78659-000-0430 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
    5NDC:78659-000-05500 mL in 1 BAG; Type 0: Not a Combination Product05/04/2020
    6NDC:78659-000-0660 mL in 1 BOTTLE; Type 0: Not a Combination Product05/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E05/04/2020
    Labeler - GREEN ELV NUTRITION, S.A. DE C.V. (951578109)
    Establishment
    NameAddressID/FEIBusiness Operations
    GREEN ELV NUTRITION, S.A. DE C.V.951578109manufacture(78659-000)
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