TLC PLUS ANESTHETIC G (LIDOCAINE GEL) GEL [RENU LABORATORIES, INC.]

TLC PLUS ANESTHETIC G (LIDOCAINE GEL) GEL [RENU LABORATORIES, INC.]
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NDC 76348-416-02
Set ID 4d0fc18f-1381-5103-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager Renu Laboratories, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART348
  • DOSAGE & ADMINISTRATION

    Directions: adults and children over 12 years

    • apply a thin layer to affected area every 6 to 8 hours
    • after applying, wash hands with soap and water
  • ACTIVE INGREDIENT

    Active Ingredient

    Lidocaine HCl 4%

  • STOP USE

    Stop Use and ask a doctor if:

    • condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more then 7 days or clear up and occur again within a few days
    • you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.
  • ASK DOCTOR

    Stop Use and ask a doctor if:

    condition worsens
    redness is present
    irritation develops
    symptoms persist for more then 7 days or clear up and occur again within a few days
    you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

  • DO NOT USE

    Do not use

    • on large areas of the body or on cut, irritated or swollen skin
    • on puncture wounds
    • for more than one week without consulting a doctor
  • INDICATIONS & USAGE

    Uses

    For the temporary relief of pain associated with minor skin procedures

  • PURPOSE

    Topical Anesthetic

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,

    ask a health professional

    before use

  • WARNINGS

    Warnings

    For external use only

    Do not use

    • on large areas of the body or on red, irritated or swollen skin
    • on puncture wounds
    • for more than one week wihout consulting a doctor
  • INACTIVE INGREDIENT

    Aloe Leaf Powder, Benzyl Alcohol, Deionized Water, Disodium EDTA, Ethyl Alcohol, Glycerin,

  • KEEP OUT OF REACH OF CHILDREN

    Keep ot of reach of children

    and pets.

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

  • PRINCIPAL DISPLAY PANEL

    JAR BOTTOM_LABELJAR SIDE

  • INGREDIENTS AND APPEARANCE
    TLC PLUS ANESTHETIC G 
    lidocaine gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-416
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS2.36 g  in 59 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE (UNII: V5VD430YW9)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-416-0259 g in 1 JAR; Type 0: Not a Combination Product07/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34807/28/2017
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-416)

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