Label: TECNU RASH RELIEF- grindelia robusta, calendula officinalis spray

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated July 5, 2023

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Grindelia Robusta 1X HPUS 0.8%

    Calendual officinalis 1X HPUS 0.4%

  • PURPOSE

    wound healing/ scar prevention

    anti-itch/pain relief

  • INDICATIONS & USAGE

    Uses:

    temporarily relieves the pain and itching of skin rashes due to

    poison oak

    poison ivy

    poison sumac

    prickly heat rash

    hives

    insect bites

    minor cuts, scrapes and burns

    helps promote healing of

    cuts

    scrapes

    chafing

    sunburn

    minor burns

    minor skin irritations

    protects skin

  • WARNINGS

    For external use only

  • DO NOT USE

    Do not use:

    if allergic to Calendula officinalis, Grindelia robusta, or any of the product's inactive ingredients

    on severe, draining rashes

    if pregnant or nursing, ask a health professional before use

  • WHEN USING

    When using this product:

    do not get into eyes

  • 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.

  • STOP USE

    Stop use and ask a doctor if

    condition worstens or if symptoms persist formore than 7 days

  • DOSAGE & ADMINISTRATION

    Directions

    adults and children 2 years and older:

    when practical, wash affected area with soap and water or use a Tecnu cleanser before the first appication to remove poison oil

    spray onto affected area as needed

    children 2 years of age: consult a doctor before use

  • STORAGE AND HANDLING

    Other information:

    store at room temperature (59-86ºF/ 15-30ºC)

    the letters "HPUS" indicate that the component in this product is officially monographed in the Homeopathic Pharmacopeia of the United States

  • INACTIVE INGREDIENT

    Inactive ingredients

    alcohol, bezethonium chloride, disodium EDTA, glycerin, menthol, polyoxyl 35 castor oil, purified water, tea tree oil, white thyme oil

  • QUESTIONS

    Questions?

    Call 1-800-482-4464

  • PRINCIPAL DISPLAY PANEL

    OUTDOOR SOULUTIONS SINCE 1962

    tecnu

    Rash Relief

    Medicated Anti-itch-Spray

    With Scar Prevention

    Stops Itching of Poison Ivy Rash

    Dries Oozing

    Promotes Healing

    Homeopathic

    6 FL. OZ. (177 mL)

    TRRS label

  • INGREDIENTS AND APPEARANCE
    TECNU RASH RELIEF 
    grindelia robusta, calendula officinalis spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51879-164
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GRINDELIA HIRSUTULA FLOWERING TOP (UNII: IDB0NAZ6AI) (GRINDELIA HIRSUTULA FLOWERING TOP - UNII:IDB0NAZ6AI) GRINDELIA HIRSUTULA FLOWERING TOP1 [hp_X]  in 1 mL
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER1 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    THYME OIL (UNII: 2UK410MY6B)  
    POLYOXYL 35 CASTOR OIL (UNII: 6D4M1DAL6O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
    WATER (UNII: 059QF0KO0R)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    MENTHOL (UNII: L7T10EIP3A)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51879-164-06177 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product07/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic07/12/2023
    Labeler - Tec Laboratories Inc. (083647792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Tec Laboratories Inc.083647792manufacture(51879-164)