Label: SP1 FORMULA- phytolacca decandra, thuja occidentalis oil

  • NDC Code(s): 61077-101-11, 61077-101-33
  • Packager: Healing Natural Oils LLC
  • 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 27, 2017

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  • Active Ingredients:


    Phytolacca decandra  - 15C HPUS
    Thuja occidentalis - 15C HPUS
  • Purpose

    Phytolacca decandra - 15C HPUS (for warts), 
    Thuja occidentalis -15C HPUS (locally for warts)

    The letters ‘HPUS’ indicate that the components in this product are officially
    monographed in the Homoeopathic Pharmacopoeia of the United States

  • Inactive Ingredients:

     Essential Oil Blend (Citrus limon peel,
    Juniperus communis berry, Melaleuca alternifolia leaf-branch, Thuja occidentalis leaf)

  • Indications:

    For the treatment of wart symptoms associated with common warts (cauliflower like appearance), plantar warts (under the feet) and flat warts.

  • Directions:

    Adults and children 4 years and over: Wash hands before and after use.
    Shake well and apply 1 or 2 drops to a cotton swab and dab directly to warts 3x daily.
    Do not oversaturate or exceed dosage.

  • Warnings:

    For external use only.

    Does not prevent the spread of warts.

    Perform skin test prior to initial use.



    Do not use if pregnant or breastfeeding.

    Keep out of reach of children.

    Keep away from eyes and mucous membranes. If swallowed get medical help
    or contact a Poison Control Center right away.

    Discontinue use if irritation occurs.

    Consult a doctor if symptoms worsen after 7 days.

  • DESCRIPTION

    Dist. by Healing Natural Oils 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA

  • PRINCIPAL DISPLAY PANEL

    Healing Natural Oils

    SP1
    Formula

    Homeopathic

    For External Use Only

    101

    11ml (0.37 fl. oz)
    amoils.com

    SP Formula Label

  • INGREDIENTS AND APPEARANCE
    SP1 FORMULA  
    phytolacca decandra, thuja occidentalis oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61077-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT15 [hp_C]  in 11 mL
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG15 [hp_C]  in 11 mL
    Inactive Ingredients
    Ingredient NameStrength
    LEMON PEEL (UNII: 72O054U628)  
    JUNIPER BERRY (UNII: O84B5194RL)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61077-101-1111 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    2NDC:61077-101-3333 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product11/06/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/06/2013
    Labeler - Healing Natural Oils LLC (113679703)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc617901350manufacture(61077-101)
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