Hemorrhoid Gel
FDA Label NDC 43406-0709

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 Hemorrhoid Gel (NDC 43406-0709). 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.

Label Section Quick Index

Otc - Active Ingredient

ACTIVE INGREDIENTS - equal amounts of: Achillea Millefolium 4X, Aesculus Hippocastanum 4X, 30C, Hamamelis Virginiana 4X, Ruscus Aculeatus 4X, Aloe Socotrina 6X, Paeonia Officinalis 6X, Ignatia Amara 12X, Nitricum Acidum 12X, Nux Vomica 12X, Phosphorus 12X, Podophyllum Peitatum 12X, Pulsatilla 12X, Ratanhia 12X, 30C, Chelidonium Majus 30C, Sulphur 30C

Indications & Usage

USES: Temporarily relieves bleeding, painful, burning &/or stinging hemorrhoids & hemorrhoid related symptoms.**

Otc - Purpose

USES: Temporarily relieves bleeding, painful, burning &/or stinging hemorrhoids & hemorrhoid related symptoms.**

Dosage & Administration

DIRECTIONS: Lubricate applicator with a small amount of gel before use. Apply to area 5 to 6 times daily, especially after a bowel movement.

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 980, Ethanol Alcohol, Organic Aloe Vera Powder, Purified Water, Sodium Hydroxide, USP Glycerin

Otc - Questions

QUESTIONS & COMMENTS?

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

References

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Package Label.Principal Display Panel

NDC:43406-0709-5

Hemorrhoid Gel

HOMEOPATHIC

 2 oz (56.7g)

* Please review the disclaimer below.