Label: ITCH RELIEF- apis mellifera, lachesis muta venom, ledum palustre twig and urtica urens liquid

  • Category: HUMAN OTC DRUG LABEL

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 April 23, 2021

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Apis mellifica 12X

  • Purpose

    stinging, pain, redness, burning

  • Active Ingredient

    Lachesis mutus 12X

  • Purpose

    burning, skin discoloration

  • Active Ingredient

    Ledum palustre 6X

  • Purpose

    itching, skin irritation

  • Active Ingredient

    Urtica urens 8X

  • Purpose

    itching, burning, skin irritation and rashes

  • Uses:

    According to homeopathic principles, the active ingredients in this product temporarily relieve minor symptoms associated with insect bites & stings and minor skin irritations due to poison ivy, oak & sumac such as: pain itching

  • Warnings:

    • For external use only.
    • According to homeopathic principles, symptoms may temporarily worsen before improving (initial exacerbation of symptoms).
    • Avoid contact with the eyes.
    • If conditions worsen or persist for more than 72 hours discontinue use and consult a physician.
  • If pregnant, trying to get pregnant or breast feeding,

    ask a health professional before use.

  • Keep out of reach of children.

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

  • Directions:

    For adults and children age 2 and over: Moisten the affected area with roller ball at short intervals several times a day until the symptoms clearly diminish. Continue to apply 3-6 times daily until the affected area is completely cleared up.

  • Other Information:

    Active ingredients are manufactured according to homeopathic principles.

  • Inactive Ingredients:

    Alcohol, 40% V/V, Vegetable glycerin

  • Questions?

    Reach our representatives at 1-800-240-9780 or getinfo@similasanusa.com.

    www.SimilasanUSA.com

  • PRINCIPAL DISPLAY PANEL


    Similasan
    ®
    Itch Relief  
    ROLL-ON
    7.5 mL/0.25
    fl oz

    Similasan®
Itch Relief  
ROLL-ON
7.5 mL/0.25 fl oz

    Similasan®
Itch Relief  
ROLL-ON
7.5 mL/0.25 fl oz

  • INGREDIENTS AND APPEARANCE
    ITCH RELIEF 
    apis mellifera, lachesis muta venom, ledum palustre twig and urtica urens liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    APIS MELLIFERA (UNII: 7S82P3R43Z) (APIS MELLIFERA - UNII:7S82P3R43Z) APIS MELLIFERA12 [hp_X]  in 7.5 mL
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM12 [hp_X]  in 7.5 mL
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG6 [hp_X]  in 7.5 mL
    URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS8 [hp_X]  in 7.5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-401-421 in 1 BOX11/01/2014
    17.5 mL in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/01/2014
    Labeler - Similasan Corporation (111566530)
    Establishment
    NameAddressID/FEIBusiness Operations
    Similasan AG481545754label(59262-401) , manufacture(59262-401) , pack(59262-401)