Label: DR. JAMES GEL (ETHANOL)- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 26, 2020

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  • ACTIVE INGREDIENT

    alcohol

  • INACTIVE INGREDIENT

    glycerin, triethanolamine, carbomer, lemon oil, aloe vera gel, hinoki oil, green tea extract, edta, 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
    DR. JAMES GEL (ETHANOL) 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73065-0005
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    LEMON OIL (UNII: I9GRO824LL)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73065-0005-1100 mL in 1 TUBE; Type 0: Not a Combination Product06/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/22/2020
    Labeler - WOORILIFE&HEALTH (694860803)
    Registrant - WOORILIFE&HEALTH (694860803)
    Establishment
    NameAddressID/FEIBusiness Operations
    WOORILIFE&HEALTH694860803manufacture(73065-0005)
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