Label: BLACK- echinacea ang., hydrastis, phytolacca, plantago, stellaria med., symphytum, trifolium prat., verbascum, arsenicum alb., bufo, lachesis, lycopodium, sepia, silicea, thuja occ. gel

  • 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 INGREDIENT

    ACTIVE INGREDIENTS: (HPUS*): Echinacea Ang 1X, Hydrastis 1X, Phytolacca 1X, Plantago 1X, Stellaria Med 1X, Symphytum 1X, Trifolium Prat 1X, Verbascum 1X, Arsenicum Alb 12X, Bufo 12X, Lachesis 12X, Lycopodium 12X, Sepia 12X, Silicea 12X, Thuja Occ 12X.

  • INDICATIONS & USAGE

    USES: Temporarily relieves itching, burning, and redness, swelling of the skin, boils, hard nodular eruptions and/or warty growths.

  • PURPOSE

    USES: Temporarily relieves itching, burning, and redness, swelling of the skin, boils, hard nodular eruptions and/or warty growths.

  • DOSAGE & ADMINISTRATION

    DIRECTIONS:  Apply a small amount to affected area or as directed by a health care professional.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

  • WARNINGS

    WARNINGS:

    • FOR TOPICAL USE ONLY.
    • Consult a physician for use in children under 12 years of age.
    • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
    • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
    • Do not use if TAMPER EVIDENT seal is broken or missing.
  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Carbomer 940, Glycerin, Organic Aloe Vera, Purified Water, Sodium Hydroxmethylglycinate.

  • QUESTIONS

    QUESTIONS & COMMENTS?

    Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

  • REFERENCES

    **The letters "HPUS" indicate the components in this product are officially monographed in the Homeopathic Pharmacopeia of the United States.

  • PRINCIPAL DISPLAY PANEL

    NDC: 43406-0135-2

    BLACK GEL

    Warts*Skin Growths

    TOPICAL HOMEOPATHIC GEL

     Net. Wt. 2oz. (56.7g)

    image description

  • INGREDIENTS AND APPEARANCE
    BLACK 
    echinacea ang., hydrastis, phytolacca, plantago, stellaria med., symphytum, trifolium prat., verbascum, arsenicum alb., bufo, lachesis, lycopodium, sepia, silicea, thuja occ. gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43406-0135
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA WHOLE1 [hp_X]  in 1 g
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL1 [hp_X]  in 1 g
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT1 [hp_X]  in 1 g
    PLANTAGO MAJOR WHOLE (UNII: W2469WNO6U) (PLANTAGO MAJOR - UNII:W2469WNO6U) PLANTAGO MAJOR WHOLE1 [hp_X]  in 1 g
    STELLARIA MEDIA (UNII: 2H03479QVR) (STELLARIA MEDIA - UNII:2H03479QVR) STELLARIA MEDIA1 [hp_X]  in 1 g
    COMFREY LEAF (UNII: DG4F8T839X) (COMFREY LEAF - UNII:DG4F8T839X) COMFREY LEAF1 [hp_X]  in 1 g
    TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) (TRIFOLIUM PRATENSE FLOWER - UNII:4JS0838828) TRIFOLIUM PRATENSE FLOWER1 [hp_X]  in 1 g
    VERBASCUM THAPSUS WHOLE (UNII: C9TD27U172) (VERBASCUM THAPSUS - UNII:C9TD27U172) VERBASCUM THAPSUS WHOLE1 [hp_X]  in 1 g
    ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE12 [hp_X]  in 1 g
    BUFO BUFO CUTANEOUS GLAND (UNII: Q59QU6N72Q) (BUFO BUFO CUTANEOUS GLAND - UNII:Q59QU6N72Q) BUFO BUFO CUTANEOUS GLAND12 [hp_X]  in 1 g
    LACHESIS MUTA VENOM (UNII: VSW71SS07I) (LACHESIS MUTA VENOM - UNII:VSW71SS07I) LACHESIS MUTA VENOM12 [hp_X]  in 1 g
    LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE12 [hp_X]  in 1 g
    SEPIA OFFICINALIS JUICE (UNII: QDL83WN8C2) (SEPIA OFFICINALIS JUICE - UNII:QDL83WN8C2) SEPIA OFFICINALIS JUICE12 [hp_X]  in 1 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE12 [hp_X]  in 1 g
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG12 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43406-0135-256.7 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product05/20/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic05/20/2007
    Labeler - Natural Creations, Inc (018022074)
    Establishment
    NameAddressID/FEIBusiness Operations
    OHM Pharma, Inc030572478manufacture(43406-0135)
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