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)
Hemcalm Suppository
FDA Label NDC 0220-9179
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Boiron for the product Hemcalm (NDC 0220-9179). 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, otc - purpose, indications & usage, warnings, otc - ask doctor/pharmacist, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
