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SPL
SPL Set ID fc221651-5d94-46e9-966b-35918e8361fb
Route
TOPICAL
Published
Effective Date 2020-05-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Echinacea Angustifolia (1 [hp_X]) Goldenseal (12 [hp_X]) Phytolacca Americana Root Plantago Major Stellaria Media Comfrey Leaf Trifolium Pratense Flower Verbascum Thapsus Arsenic Cation (3+) Bufo Bufo Cutaneous Gland Lachesis Muta Venom Lycopodium Clavatum Spore Sepia Officinalis Juice Silicon Dioxide Thuja Occidentalis Leafy Twig
Inactive Ingredients
Carbomer 940 Glycerin Aloe Vera Leaf Water Sodium Hydroxymethylglycinate

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2007-05-20

Description

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.


Medication Information

Warnings and Precautions

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.
Indications and Usage

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

Dosage and Administration

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

Description

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.

Section 34093-5

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

Section 50565-1

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.

Section 51727-6

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

Section 51945-4

NDC: 43406-0135-2

BLACK GEL

Warts*Skin Growths

TOPICAL HOMEOPATHIC GEL

 Net. Wt. 2oz. (56.7g)

Section 53413-1

QUESTIONS & COMMENTS?

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

Section 55105-1

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

Section 55106-9

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.


Structured Label Content

Indications and Usage (34067-9)

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

Dosage and Administration (34068-7)

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

Warnings and Precautions (34071-1)

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.
Section 34093-5 (34093-5)

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

Section 50565-1 (50565-1)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

NDC: 43406-0135-2

BLACK GEL

Warts*Skin Growths

TOPICAL HOMEOPATHIC GEL

 Net. Wt. 2oz. (56.7g)

Section 53413-1 (53413-1)

QUESTIONS & COMMENTS?

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

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

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.


Advanced Ingredient Data


Raw Label Data

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