Label: GUNA-DERMO- aldesleukin - arsenic trioxide - atropa belladonna - canakinumab - echinacea angustifolia - graphite - melatonin - plantago major - solanum dulcamara flower - sulfur - solution/ drops

  • 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 December 21, 2018

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  • ACTIVE INGREDIENTS/PURPOSE

    ARSENICUM ALBUM        6C    SKIN BLISTERS
    BELLADONNA        6C    SWELLING
    DULCAMARA        6C    MUSCLE SORENESS
    ECHINACEA ANGUSTIFOLIA    6C    ANTI-INFECTION
    GRAPHITES        6C    SKIN INFLAMMATION
    INTERLEUKIN 1 BETA    7C    IMMUNE STRENGTHENING
    INTERLEUKIN 2        4C    IMMUNE STRENGTHENING
    MELATONIN        4C    HORMONAL SUPPORT
    PLANTAGO MAJOR        4C    DETOXIFICATION
    SULPHUR            6C    SENSITIVE SKIN

  • USES

    Temporary relief of symptoms of general skin irritation and rashes such as:

    • Itching
    • Dryness
    • Hypersensitivity
  • WARNINGS

    Stop use and ask doctor if symptoms persist more than 5 days.
    If pregnant or breast-feeding ask a health professional before use.
    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
    Contains ethyl alcohol 30%

  • PREGNANCY

    If pregnant or breast-feeding ask a doctor before use

  • WARNINGS

    Keep this and all medicines out of reach of children

  • DIRECTIONS



    Adults and children 12 years and older 20 drops in a little water, 2 times per day

    Children between 12 years and 6 years of age 10 drops in a little water, 2 times per day

    Children under 6 years 5 drops in a glass of water, 2 times per day

  • QUESTIONS

    Questions?: info@gunainc.com, tel. (484) 223-3500

  • INDICATIONS & USAGE

    Take 15 minutes before meals

  • INACTIVE INGREDIENT

    Inactive ingredient. Ethyl alcohol 30%.

  • PRINCIPAL DISPLAY PANEL

    5USDER-Rev02-21-05-18

  • INGREDIENTS AND APPEARANCE
    GUNA-DERMO 
    aldesleukin - arsenic trioxide - atropa belladonna - canakinumab - echinacea angustifolia - graphite - melatonin - plantago major - solanum dulcamara flower - sulfur - solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:17089-295
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALDESLEUKIN (UNII: M89N0Q7EQR) (ALDESLEUKIN - UNII:M89N0Q7EQR) ALDESLEUKIN4 [hp_C]  in 30 mL
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE6 [hp_C]  in 30 mL
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_C]  in 30 mL
    CANAKINUMAB (UNII: 37CQ2C7X93) (CANAKINUMAB - UNII:37CQ2C7X93) CANAKINUMAB7 [hp_C]  in 30 mL
    ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA6 [hp_C]  in 30 mL
    GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O) GRAPHITE6 [hp_C]  in 30 mL
    MELATONIN (UNII: JL5DK93RCL) (MELATONIN - UNII:JL5DK93RCL) MELATONIN4 [hp_C]  in 30 mL
    PLANTAGO MAJOR (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR4 [hp_C]  in 30 mL
    SOLANUM DULCAMARA FLOWER (UNII: W6J1279A6K) (SOLANUM DULCAMARA FLOWER - UNII:W6J1279A6K) SOLANUM DULCAMARA FLOWER6 [hp_C]  in 30 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR6 [hp_C]  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M) 9 mL  in 30 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17089-295-181 in 1 BOX12/21/2018
    130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/23/2006
    Labeler - Guna spa (430538264)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guna spa338587646manufacture(17089-295)
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