BURN RECOVERY (CALENDULA OFFICINALIS FLOWERING TOP, LYTTA VESICATORIA, ECHINACEA, UNSPECIFIED, URTICA URENS) SPRAY [SIMILASAN CORPORATION]

BURN RECOVERY (CALENDULA OFFICINALIS FLOWERING TOP, LYTTA VESICATORIA, ECHINACEA, UNSPECIFIED, URTICA URENS) SPRAY [SIMILASAN CORPORATION]
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NDC 59262-400-41
Set ID 2dfc01c1-4d57-4862-831e-eeef5d767499
Category HUMAN OTC DRUG LABEL
Packager Similasan Corporation
Generic Name
Product Class
Product Number
Application Number
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Calendula officinalis 4X

  • Purpose

    aids in skin recovery, soothes redness

  • Active Ingredient

    Cantharis 6X

  • Purpose

    burns/sunburns, itching

  • Active Ingredient

    Echinacea 4X

  • Purpose

    redness, burning pain

  • Active Ingredient

    Urtica urens 4X

  • Purpose

    stinging, itching, scalds, burns/sunburns

  • Uses:

    According to homeopathic principles, the active ingredients in this product temporarily relieve pain, redness, and itching associated with sunburns or minor burns.

  • Warnings:

    • For external use only. Do not use on open wounds, on mucous membranes or on serious burns.
    • Do not use if you have a known case of hypersensitivity to Asteracea flowers.
    • Initial exacerbation of symptoms may occur.
    • Avoid contact with the eyes.
    • If conditions worsen or persist for more than 72 hours discontinue use and consult a physician.
    • Severe burns must immediately be treated by a physician.
  • If 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: Spray on the affected area 3-4 times a day.

    Can be used as a compress by saturating a clean cloth or gauze. Place on affected area and secure with a bandage. Re-moisten several times a day.

  • Other Information:

    Active ingredients are manufactured according to homeopathic principles.

  • Inactive Ingredients:

    Alcohol, 25%

  • Questions?

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

    www.SimilasanUSA.com

  • PRINCIPAL DISPLAY PANEL

    NDC 59262-400-41
    Similasan®
    Burn
    Recovery
     
    COOLING SPRAY
    90
    mL/3.04 fl oz

    PRINCIPAL DISPLAY PANEL
NDC 59262-400-41
Similasan®
Burn 
Recovery 
COOLING SPRAY
90 mL/3.04 fl oz

  • INGREDIENTS AND APPEARANCE
    BURN RECOVERY 
    calendula officinalis flowering top, lytta vesicatoria, echinacea, unspecified, urtica urens spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59262-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP4 [hp_X]  in 90 mL
    LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA6 [hp_X]  in 90 mL
    ECHINACEA, UNSPECIFIED (UNII: 4N9P6CC1DX) (ECHINACEA, UNSPECIFIED - UNII:4N9P6CC1DX) ECHINACEA, UNSPECIFIED4 [hp_X]  in 90 mL
    URTICA URENS (UNII: IHN2NQ5OF9) (URTICA URENS - UNII:IHN2NQ5OF9) URTICA URENS4 [hp_X]  in 90 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59262-400-411 in 1 BOX
    190 mL in 1 BOTTLE, SPRAY; 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(59262-400) , MANUFACTURE(59262-400) , PACK(59262-400)

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