Black
FDA Label NDC 43406-0135

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Natural Creations, Inc for the product Black (NDC 43406-0135). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, otc - purpose, dosage & administration, otc - keep out of reach of children, warnings, inactive ingredient, otc - questions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - 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.

Otc - 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.

Otc - 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.

Otc - 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.

Package Label.Principal Display Panel

NDC: 43406-0135-2

BLACK GEL

Warts*Skin Growths

TOPICAL HOMEOPATHIC GEL

 Net. Wt. 2oz. (56.7g)

Image Description (Blackgel)

Image Description (Blackgel)

* Please review the disclaimer below.