Label: TECNU IVY COMPLETE KIT- ivy treatment kit

  • NDC Code(s): 51879-400-04, 51879-410-04
  • Packager: Tec Laboratories Inc.
  • 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 January 3, 2023

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  • ACTIVE INGREDIENT

    Diphenhydramine HCL 2%

  • PURPOSE

    Purpose Topical analgesic/antihistamine

  • INDICATIONS & USAGE

    for the temporary relief of pain and itching associated with:

    •minor burns•sunburn•minor cuts•scrapes•insect bites

    •minor skin irritaitons

    •rashes due to poison ivy, poison oak and poison sumac

  • WARNINGS

    Do not use:

    • on large areas of the body
    • with any other product containing diphenhydramine, even on taken by mouth
  • ASK DOCTOR

    Ask a doctor before use:

    • on chicken pox
    • on measles
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    • if swallowed, get medical help or contact a poison control center right away
  • WHEN USING

    When using this product:

    • avoid contact with eyes
  • STOP USE

    Stop use and ask a doctor if:

    • condition worsens
    • symptoms persist for more than 7 days or clear up and occur again within a few days
  • DOSAGE & ADMINISTRATION

    Directions

    • do not use more than directed
    • adults and children 2 years of age and older:
      • cleanse skin with soap and warm water and dry affected area
      • apply to affected area not more than 3 times daily
      • may be covered with a bandage; if bandage let dry first
      • children under 2 years of age: do not use, consult a doctor
  • STORAGE AND HANDLING

    Other information

    Store at 59 to 86°F (15 to 30°C)

  • INACTIVE INGREDIENT

    benzethonium chloride, disodium EDTA, fragrance, hypromellose, menthol, polysorbate 20, purified water, sodium metabisulfite, zinc acetate

  • QUESTIONS

    Questions?

    Call 1-800-482-4464

    Serious side effects may be reported to this number

  • PRINCIPAL DISPLAY PANEL

    Ivy Complete Kit

  • INGREDIENTS AND APPEARANCE
    TECNU IVY COMPLETE KIT 
    ivy treatment kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51879-400
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51879-400-041 in 1 CARTON; Type 0: Not a Combination Product01/16/2023
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE 113.4 g
    Part 1 of 1
    TECNU TREAT 
    diphenhydramine hydrochloride gel
    Product Information
    Item Code (Source)NDC:51879-410
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE20 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ZINC ACETATE (UNII: FM5526K07A)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51879-410-04113.4 g in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/16/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34801/16/2023
    Labeler - Tec Laboratories Inc. (083647792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tec Laboratories, Inc.083647792manufacture(51879-400)
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