HEMCALM- horse chestnut, hamamelis virginiana root bark/stem bark, paeonia officinalis root, krameria lappacea root suppository

HemCalm by

Drug Labeling and Warnings

HemCalm by is a Homeopathic medication manufactured, distributed, or labeled by Boiron, Boiron, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

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.

ASK DOCTOR/PHARMACIST

Ask a doctor before use in case of bleeding.

STOP USE

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

PREGNANCY OR BREAST FEEDING

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

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.

SPL UNCLASSIFIED SECTION

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

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEMCALM 
horse chestnut, hamamelis virginiana root bark/stem bark, paeonia officinalis root, krameria lappacea root suppository

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9179
Route of Administration	RECTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PAEONIA OFFICINALIS ROOT (UNII: 8R564U2E1P) (PAEONIA OFFICINALIS ROOT - UNII:8R564U2E1P)	PAEONIA OFFICINALIS ROOT	2 [hp_X]
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ)	HORSE CHESTNUT	7 [hp_X]
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	2 [hp_X]
KRAMERIA LAPPACEA ROOT (UNII: P29ZH1A35Z) (KRAMERIA LAPPACEA ROOT - UNII:P29ZH1A35Z)	KRAMERIA LAPPACEA ROOT	7 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
HARD FAT (UNII: 8334LX7S21)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9179-67	10 in 1 BOX; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		01/01/2020

Labeler - Boiron (282560473)

Registrant - Boiron, Inc. (014892269)

Establishment
Name	Address	ID/FEI	Business Operations
Boiron		282560473	manufacture(0220-9179)