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  5. Label Information: Hemorrhoid

FDA Label for Hemorrhoid

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INDICATIONS & USAGE
    3. OTC - PURPOSE
    4. DOSAGE & ADMINISTRATION
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. WARNINGS
    7. INACTIVE INGREDIENT
    8. OTC - QUESTIONS
    9. REFERENCES
    10. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hemorrhoid Product Label

The following document was submitted to the FDA by the labeler of this product Natural Creations, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



ACTIVE INGREDIENTS (*HPUS) - equal amounts of: Aesculus Hipp 4X, 30C, Hamamelis 4X, 30C, Aloe 30C, Calc Phos 30C, Carbo An 30C, Carbo Veg 30C, Lachesis 30C, Lycopodium 30C, Muriaticum Ac 30C, Nitricum Ac 30C, Nux Vom 30C, Paeonia 30C, Ratanhia 30C, Sepia 30C, Sulphur 30C


Indications & Usage



USES: Temporarily relieves burning, bleeding, painful, itching hemorrhoids.**


Otc - Purpose



USES: Temporarily relieves burning, bleeding, painful, itching hemorrhoids.**


Dosage & Administration



DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, 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:

  • 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: Ethyl Alcohol USP, Purified Water


Otc - Questions



QUESTIONS & COMMENTS?

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


References



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

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


Package Label.Principal Display Panel



NDC:43406-0681-1

Hemorrhoid

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol


* Please review the disclaimer below.