FDA.reportPublic FDA data

HemCalm

Manufacturer
Boiron | Boiron, Inc.
Effective date
2024-02-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:26:05

Label at a glance#

ProductHemCalm
Active ingredientPAEONIA OFFICINALIS ROOT, HORSE CHESTNUT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, KRAMERIA LAPPACEA ROOT
Label structure15 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients** (in each suppository)

Aesculus hippocastanum 7X HPUS (0.01 g)

Hamamelis virginiana 2X HPUS (0.01 g)

Paeonia officinalis 2X HPUS (0.01 g)

Ratanhia 7X HPUS (0.01 g)

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose*

Aesculus hippocastanum 7X HPUS (0.01g) ... Reduces swelling and relieves stinging pain associated with internal and 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 internal and external hemorrhoids

Ratanhia 7X HPUS (0.01g) ... Relieves itching and discomfort from internal and external hemorrhoids, especially during and after bowel movements

INDICATIONS & USAGE SECTION

Uses*

temporarily relieves symptoms of hemorrhoids such as

  • burning
  • itching
  • swelling
  • pain
  • discomfort
  • helps shrink swollen hemorrhoids
  • relieves hemorrhoid symptoms following childbirth

WARNINGS SECTION

For rectal use only.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor before use in case of bleeding.

OTC - WHEN USING SECTION

When using this product, do not exceed the recommended daily dosage unless directed by a doctor.

OTC - STOP USE SECTION

Stop use and ask a doctor if symptoms persist for more than 7 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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.

SPL UNCLASSIFIED SECTION

Other information

  • 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)

SPL UNCLASSIFIED SECTION

10 Suppositories

Hemorrhoid Relief*

Burning Itching Pain Discomfort*

Plant Powered Relief

Reduces Swelling

Paraben-Free

*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.

INACTIVE INGREDIENT SECTION

Hard fat

OTC - QUESTIONS SECTION

1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com Info@boiron.com
Distributed by Boiron, Inc. Newtown Square, PA 19073

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabellabellabelETU1F47 082019ETU1F47 082019labellabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-9179-67HemCalm10 in 1 BOXSUPPOSITORY105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-9179HEMCALM (HORSE CHESTNUT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, PAEONIA OFFICINALIS ROOT, KRAMERIA LAPPACEA ROOT) SUPPOSITORY [BOIRON]5Current NDC, Legacy NDC, 1 package rows20240216_91ce4f52-d761-a3b5-e053-2995a90a45df.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-91790220-9179-67

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
PAEONIA OFFICINALIS ROOT8R564U2E1PACTIB
HORSE CHESTNUT3C18L6RJAZACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
HARD FAT8334LX7S21IACT
KRAMERIA LAPPACEA ROOTP29ZH1A35ZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HemCalmHORSE CHESTNUT, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK, PAEONIA OFFICINALIS ROOT, KRAMERIA LAPPACEA ROOTBoiron91ce4f52-d761-a3b5-e053-2995a90a45df2024-02-14WarningsExact identifier
ndc (package): 0220-9179-67
ndc (product): 0220-9179
ndc11 (package): 00220917967
spl id: 115e1bfb-1698-d567-e063-6394a90a78e5
spl set id: 91ce4f52-d761-a3b5-e053-2995a90a45df

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.