TLC PLUS ANESTHETIC S (LIDOCAINE) SPRAY [RENU LABORATORIES, INC.]

TLC PLUS ANESTHETIC S (LIDOCAINE) SPRAY [RENU LABORATORIES, INC.]
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NDC 76348-415-01
Set ID 433d5e6b-f608-0d93-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager Renu Laboratories, Inc.
Generic Name
Product Class Amide Local Anesthetic, Antiarrhythmic
Product Number
Application Number PART346
  • ACTIVE INGREDIENT

    Lidocaine HCl 4%

  • PURPOSE

    Topical Anesthetic

  • INDICATIONS & USAGE

    For the temporary relief of pain associated with minor skin procedures

  • WARNINGS

    For external use only

  • 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
  • WHEN USING

    When using this product

    • Use only as directed. Read and follow all directions and warnings on this label.
    • rare cases of serious burns have been reported with products of this type
    • do not bandage or apply local heat (such as heating pads) to the area of use or use with a medicated patch
    • avoid contact with eyes and mucous membranes
    • a transient burning sensation may occur upon application but generally disappears in several days
  • STOP USE

    Stop use and ask a doctor if

    • Condition worsens
    • redness is present
    • irritation develops
    • symptoms persist for more than 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
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children and pets

    • If swallowed, get medical help or contact a poison control center right away
  • INSTRUCTIONS FOR USE

    Directions

    adults and children over 12 years:

    • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
    • after applying, wash hands with soap and water

    children 12 years or younger

    • ask a doctor
  • INACTIVE INGREDIENT

    Aloe Barbadensis Leaf Powder, Benzyl Alcohol, Deionized Water, Disodium EDTA, Ethyl Alcohol SD 40B, Glycerin

  • QUESTIONS

    877 2-TLC-PLUS

  • STATEMENT OF IDENTITY

    TLC PLUS

    Anesthetic

    Spray

    2 oz / 59 ml

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children over 12 years:

    • apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24-hour period
    • after applying, wash hands with soap and water

  • PRINCIPAL DISPLAY PANEL

    TLC Plus Anesthetic Spray 2 oz

  • INGREDIENTS AND APPEARANCE
    TLC PLUS ANESTHETIC S 
    lidocaine spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76348-415
    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
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALOE (UNII: V5VD430YW9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76348-415-0159 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/28/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34607/28/2017
    Labeler - Renu Laboratories, Inc. (945739449)
    Establishment
    NameAddressID/FEIBusiness Operations
    Renu Laboratories, Inc.945739449manufacture(76348-415)

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