FDA Label for Hemcalm
View Indications, Usage & Precautions
Hemcalm Product Label
The following document was submitted to the FDA by the labeler of this product Boiron. 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
Aesculus hippocastanum 7X HPUS (0.01g), Hamamelis virginiana 2X HPUS (0.01g), Paeonia officinalis 2X HPUS (0.01g), Ratanhia 7X HPUS (0.01g)
Otc - Purpose
Aesculus hippocastanum 7X HPUS (0.01g) Reduces swelling and relieves stinging pain associated with external hemorrhoids*
Hamamelis virginiana 2X HPUS (0.01g) Relieves burning, itching and discomfort associated with hemorrhoids*
Paeonia officinalis 2X HPUS (0.01g) Relieves burning pain and oozing associated with external hemorrhoids*
Ratanhia 7X HPUS (0.01g) Relieves itching and discomfort from external hemorrhoids, especially during and after bowel movements*
Indications & Usage
Temporarily relieves symptoms of hemorrhoids such as: burning, itching, swelling, pain, discomfort. Helps shrink swollen hemorrhoid relieves hemorroid symptoms following childbirth
Warnings
For rectal use only.
Otc - Ask Doctor/Pharmacist
Ask a doctor before use in case of bleeding.
Otc - Stop Use
Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
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.
Dosage & Administration
Adults and children 12 years of age and older: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. Insert 1 HemCalm suppository rectally morning and night.
Children under 12 years of age: Ask a doctor.
Other
Do not use if the suppository seal is broken.
Suppository shape and appearance will change when exposed to heat.
do not store above 86° F (30° C)
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.
The letter "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmcopeia of the United States.
Inactive Ingredient
Hard fat
Otc - Questions
1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com [email protected]
Distributed by Boiron, Inc. Newtown Square, PA 19073
* Please review the disclaimer below.