Label: HERBA PURGO HANDS SANITIZER GEL(ETHANOL)- 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 September 2, 2020

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    alcohol

  • INACTIVE INGREDIENT

    glycerim, triethanolamine, carbomer, aloe barbadensis leaf extract, propylene glycol, citrus limon (lemon) fruit oil, green tea extract, hinoki oil, sage extract, calendula extract, water

  • PURPOSE

    antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    Take moderate amount on hands and rub well to dry

  • INDICATIONS & USAGE

    • Adults and children 2 years of age and older

    Brush teeth thoroughly preferably after each meal or at least twice a day or as directed by a dentist or docter.

    • Children under 6 years

    To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established.

    • Children under 2 years

    Consult a dentist or doctor

  • WARNINGS

    1) Be careful not to swallow it, and rinse your mouth thoroughly after use.

    2) If any abnormalities such as gum or mouth damage are caused by using this toothpaste, stop using the product and consult a doctor or dentist.

    3) For children under 6 years of age, use a small amount of pea toothpaste per serving and use it under the supervision of a guardian to avoid sucking or swallowing.

    4) If a child under 6 years of age swallows a large amount, consult a doctor or dentist immediately.

    5) Keep out of reach of children under 6 years old.

  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    HERBA PURGO HANDS SANITIZER GEL(ETHANOL) 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73065-0006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL350 mL  in 500 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CITRUS X LIMON FRUIT OIL (UNII: 0HNC1J1YED)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73065-0006-1500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product09/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A09/02/2020
    Labeler - WOORILIFE&HEALTH (694860803)
    Registrant - WOORILIFE&HEALTH (694860803)
    Establishment
    NameAddressID/FEIBusiness Operations
    WOORILIFE&HEALTH694860803manufacture(73065-0006)