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  5. Label Information: Hemorrhoid Care

FDA Label for Hemorrhoid Care

View Indications, Usage & Precautions

Table of Contents

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

Hemorrhoid Care Product Label

The following document was submitted to the FDA by the labeler of this product Apotheca Company. 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:  Hamamelis virginiana 1X, Aesculus hippocastanum 1X, 30C, Aloe socotrina 6X, Paeonia officinalis 6X, Ignatia amara 12X, Lycopodium clavatum 12X, Nitricum acidum 12X, Nux vomica 12X, Phosphorus 12X, Podophyllum peltatum 12X, Pulsatilla 12X, Sulphur 12X, Ratanhia 12X, 30X,  Chelidonium majus 30C.


Otc - Purpose



INDICATIONS:  For temporary relief of itching and discomfort associated with hemorrhoids.


Warnings



WARNINGS:  If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place

For topical use only.


Dosage & Administration



DIRECTIONS:  Apply a small amount externally to the affected area up to 6 times daily or after each bowel movement.  Children under 12 years of age: Consult a doctor.


Inactive Ingredient



INACTIVE INGREDIENTS:  Citric acid, Ethanol, Glycerin, Hydroxyethylcellulose, Purified water, Sodium benzoate.


Otc - Keep Out Of Reach Of Children



KEEP OUT OF REACH OF CHILDREN.  If swallowed, get medical help or contact a Poison Control Center right away.


Indications & Usage



INDICATIONS:  For temporary relief of itching and discomfort associated with hemorrhoids.


Otc - Questions



Dist. By:

MedCare Group

Boothwyn, PA 19060

302-260-3111

www.medcaregroups.com



Package Label.Principal Display Panel



MEDCARE

Hemorrhoid Care

HOMEOPATHIC GEL

Net. Wt. 2 OZ

Hemorrhoid Care - mm1

Hemorrhoid Care - mm1


* Please review the disclaimer below.