Label: NUNATURE FIRST AID GEL- lidocaine hci/benzethonium chloride 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 October 2, 2023

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  • ACTIVE INGREDIENT

    Benzethonium Chloride 0.2%

    Lidocaine Hydrochloride 2.5%

  • INDICATIONS & USAGE

    Uses

    • ​​​First aid to help prevent infection in minor:
    • cuts
    • scrapes
    • burns
    • For the temporary relief of pain or discomfort in minor:
    • cuts
    • scrapes
    • burns

  • WARNINGS

    Warnings

    For external use only

  • DO NOT USE

    Do not use

    • in large quantitiies particularly over raw surfaces or blister areas
  • WHEN USING

    When using this product

    avoid contact with eyes

  • STOP USE

    Stop use and ask a doctor if

    • symptoms last for more than 7 days or clear up and occur again within a few days
    • conditions worsens
  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

    if swallowed, get medical help or contact Poison Control center right away

  • DOSAGE & ADMINISTRATION

    Directions

    • adults and children 2 years of age and older: clean the affected area whenever possible
    • apply to affected area not more than 3 to 4 times daily
    • may be covered with a sterile bandange;if bandaged, let dry first
    • children under 2 years of age: do not use, consult a doctor

  • STORAGE AND HANDLING

    Other information

    Store at 59-86ºF(15-30ºC)

  • INACTIVE INGREDIENT

    allantoin, aminomethyl propanol, carbomer, disodium EDTA, glycerin, polyoxyl 35 castor oil, purified water, sodium carbonate, sodium metabisulfite, tea tree oil, white thyme oil.

  • QUESTIONS

    Questions?

    Call 1-800-482-4464. Serious side effects associated with this product may be reported to this number.

  • PURPOSE

    Topical Analgestic and First Aid Antiseptic

  • PRINCIPAL DISPLAY PANEL

    NuNature First Aid Gel

  • INGREDIENTS AND APPEARANCE
    NUNATURE FIRST AID GEL 
    lidocaine hci/benzethonium chloride gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51879-211
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE2 mg  in 1 g
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE25 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    TEA TREE OIL (UNII: VIF565UC2G)  
    CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    THYME OIL (UNII: 2UK410MY6B)  
    ALLANTOIN (UNII: 344S277G0Z)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
    SODIUM CARBONATE (UNII: 45P3261C7T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51879-211-0128.3 g in 1 TUBE; Type 0: Not a Combination Product08/11/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34808/11/2022
    Labeler - Tec Laboratories Inc (083647792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tec Laboratories Inc083647792manufacture(51879-211)
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