Label: ABUNDANT BEAUTY BY DESIGN - HAND SANITIZER 70%- ethyl 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 10, 2020

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  • SPL UNCLASSIFIED SECTION

    Before use, please read label instructions.

  • ACTIVE INGREDIENT

    Active Ingredient Ethyl Alcohol 70%

  • PURPOSE

    Purpose Antiseptic

  • INDICATIONS & USAGE

    Uses Antiseptic (skin) cleanser, Medicated (skin) cleanser, Antibacterial (skin) cleanser, Kills harmful bacteria/germs, Effective in destroying (harmful) bacteria to provide antiseptic cleansing, For personal hand hygiene to help prevent the spread of bacteria

  • WARNINGS

    Warnings For external use only.

    When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops.

    Keep out of reach of children. If swallowed, call a poison control center or get medical help right away.

  • DOSAGE & ADMINISTRATION

    Directions Adults and children over 2 years, For occasional and personal domestic use, Supervise children when they use this product.

    Rub thoroughly into hands for at least 30 seconds. Allow to dry

  • INACTIVE INGREDIENT

    Inactive Ingredients Water, astragalus gummifier gum, glycerin, triisopropanolamine, aminomethyl propanol, lactic acid, phenoxyethanol, caprylyl glycol, eucalyptus oil.

  • SPL UNCLASSIFIED SECTION

    with Eucalyptus Oil

    DISINFECTANT FOR HANDS

    Clean, Protect and Moisturize

    Kills Harmful Bacteria and Germs

    Manufactured for/Manufacturer pour

    Abundant Beauty by Design

    Somerset, MA USA.

    Phone: 1-877-606-7266 | Téléphone : 1-877-606-7266

    Made in Brazil | Fabriqué au Brésil

    Anvisa: 25351.235326/2020-59

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ABUNDANT BEAUTY BY DESIGN - HAND SANITIZER 70% 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78667-667
    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)  
    TRAGACANTH (UNII: 2944357O2O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIISOPROPANOLAMINE (UNII: W9EN9DLM98)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78667-667-011000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/04/2020
    2NDC:78667-667-9090 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/04/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/04/2020
    Labeler - GYP INDUSTRIA DE COSMETICOS EIRELI (926587780)
    Establishment
    NameAddressID/FEIBusiness Operations
    GYP INDUSTRIA DE COSMETICOS EIRELI926587780manufacture(78667-667)
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