Label: HAND SANITIZER- ethanol gel

  • NDC Code(s): 51384-002-01
  • Packager: BOTANICALS INTERNACIONAL S.A. DE C.V
  • 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 17, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • 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.

  • Purpose

    Antiseptic

  • Warnings

    Warnings

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

  • Directions

    Direction:

    • Put enough product in your palm to cover hands and rub hands together briskly until dry.
    • Children under 6 years old should be supervised when using this product.
  • Uses

    Use: hands sanitizer to help decrease bacteria on the skin

  • Stop use and ask a doctor

    Stop use and ask a doctor if irritation or rash appears and lasts.

  • When using this product

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

  • Inactive ingredients

    Inactive ingredients:

    water 28%, glycerin 1%, carbopol 940 0.50%,TEA 85 0.50%,

  • Other information

    Store below 110 oF (43 oC)

    May discolor certain fabrics

  • Principal Display Panel

    NDC: 51384-002-01

    LabelLabel

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethanol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51384-002
    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) 28 mL  in 100 mL
    CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L) 0.5 mL  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 1 mL  in 100 mL
    TROLAMINE (UNII: 9O3K93S3TK) 0.5 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51384-002-01900 mL in 1 BOTTLE; Type 0: Not a Combination Product05/13/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/13/2020
    Labeler - BOTANICALS INTERNACIONAL S.A. DE C.V (823968961)
    Registrant - BOTANICALS INTERNACIONAL S.A. DE C.V. (823968961)
    Establishment
    NameAddressID/FEIBusiness Operations
    BOTANICALS INTERNACIONAL S.A. DE C.V.823968961manufacture(51384-002)
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