Label: HAND SANITIZER AGAVESPA SKINCARE- 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 May 4, 2020

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  • Drug Facts

  • Active ingredients

    Ethyl Alcohol (70% v/v)

    Purpose

    Antiseptic

  • Uses

    • to help reduce bacteria on the skin.
  • Warnings

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

    When using this product

    do not use on damaged or broken skin.  Do not leave near fire.  Wash with enough water, if it gets into eyes.  Do not drink.

    Stop use and ask a doctor if

    irritation and redness develops.

    Keep out of reach of children.

    In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

  • Directions

    • apply enough gel to wet hands and rub together until dry.  Use 1 to 3 times daily.
  • ​Other information

    • store below 73.4 oF (23 oC)
  • Inactive Ingredients

    Water, agave tequilana weber (blue agave) extract, aloe barbadensis (aloe vera) extract, aloe barbadensis (aloe vera) extract, triethanolamine, carbomer, citrus nobilis (mandarin) essential oil, citrus tangerina (tangerine) essential oil, citrus aurantifolia (mexica lime) essential oil, citrus grandis (grapefruit) essential oil, glycerin, caprylys glycol, decylene glycol, benzoic acid, carmine.

  • Questions, Comments

    • Call 956-943-7121
  • Package Labeling

    Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER AGAVESPA SKINCARE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77056-000
    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
    WATER (UNII: 059QF0KO0R)  
    AGAVE TEQUILANA LEAF (UNII: 05545M0E3M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    MANDARIN OIL (UNII: NJO720F72R)  
    LIME OIL (UNII: UZH29XGA8G)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DECYLENE GLYCOL (UNII: S57M60MI88)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77056-000-011000 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/01/2020
    Labeler - Vidanos Easy Cleaning Rentals LLC (117475109)
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