Label: DIABETIC FIRST AID GEL PROFESSIONAL- benzalkonium chloride, lidocaine hydrochloride 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 9, 2021

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  • Active Ingredients

    Benzalkonium Chloride 0.13% .................Topical Antiseptic
    Lidocaine Hydrochloride 0.5% .................Topical Analgesic

  • Purpose

    Topical Antiseptic
    Topical Analgesic

  • Uses

    First aid to help prevent infection in minor:

    ■cuts ■scrapes ■burns

    Temporarily relieves pain and itching associated with:

    ■minor burns ■cuts ■scrapes ■insect bites ■minor skin irritations

  • Warnings

    For external use only

  • Do not use

    • in the eyes
    • over large areas of the body
    • in large quantities, particularly over raw surfaces or blistered areas
  • Ask a doctor before use if you have

    • deep or puncture wounds
    • animal bites
    • serious burns
  • Stop use and ask a doctor if

    • condition or symptoms get worse or last more than 1 week
    • symptoms clear up and occur again within a few days
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Adults and children 12 years of age and older:

    • clean the affected area
    • apply a small amount of this product on the area 1 to 3 times daily
    • may be covered with a sterile bandage
    • if bandaged, let dry first


    Children under 12 years of age: consult a doctor

  • Other information

    Store at room temperature

  • Inactive Ingredients

    Water, Glycerin, Inula Viscosa Flower/Leaf/Stem Extract, Aloe Barbadensis Leaf Juice, Xanthan Gum, Phenoxyethanol, Allantoin, Tocopheryl Acetate, Ethylhexylglycerin, Gluconolactone, Polyvinyl Alcohol, Alcohol, Citric Acid, Sodium Benzoate, Potassium Sorbate

  • Questions?

    Call toll free 1-844-474-2552 or visit www.lavior.com

  • PRINCIPAL DISPLAY PANEL

    Diabetic First Aid Gel Pro

  • INGREDIENTS AND APPEARANCE
    DIABETIC FIRST AID GEL PROFESSIONAL 
    benzalkonium chloride, lidocaine hydrochloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71521-393
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS0.5 g  in 100 g
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    DITTRICHIA VISCOSA WHOLE (UNII: 3SYW69FH88)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71521-393-5050 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/31/2021
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/31/2021
    Labeler - Lavior Inc. (080685327)
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