HEMCALM- horse chestnut, collinsonia canadensis root, hamamelis virginiana root bark/stem bark ointment

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 1X HPUS 1.3%, COLLINSONIA CANADENSIS 1X HPUS 1.3%, HAMAMELIS VIRGINIANA 1X HPUS 1.3%

PURPOSE

AESCULUS HIPPOCASTANUM 1X HPUS 1.3% REDUCES SWELLING AND RELIEVES STINGING PAIN ASSOCIATED WITH EXTERNAL HEMORRHOIDS*

COLLINSONIA CANADENSIS 1X HPUS 1.3% RELIEVES HEMORROIDS ASSOCIATED WITH CONSTIPATION*

HAMAMELIS VIRGINIANA 1X HPUS 1.3% RELIEVES BURNING, ITCHING AND DISCOMFORT ASSOCIATED WITH HEMORRHOIDS*

INDICATIONS & USAGE

TEMPORARILY RELIEVES SYMPTOMS OF HEMORRHOIDS SUCH AS: BURNING, ITCHING, SWELLING, PAIN, DISCOMFORT. HELPS SHRINK SWOLLEN HEMORRIODS. RELIEVES HEMORRHOID SYMPTOMS FOLLOWING CHILDBIRTH.

WARNINGS

FOR EXTERNAL USE ONLY.

DO NOT PUT THIS PRODUCT INTO THE RECTUM BY USING FINGERS OR ANY MECHANICAL DEVICE OR APPLICATOR.

WHEN USING THIS PRODUCT, DO NOT EXCEED THE RECOMMENDED DAILY DOSAGE UNLESS DIRECTED BY A DOCTOR.

ASK DOCTOR

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, GENTLY CLEANSE THE AFFECTED AREA WITH MILD SOAP AND WARM WATER AND RINSE THROUGHLY. GENTLY DRY BY PATTING OR BLOTTING WITH TOILET TISSUE OR A SOFT CLOTH BEFORE APPLICAITON OF PRODUCT. APPLY HEMCALM OINTMENT EXTERNALLY TO THE AFFECTED AREA UP TO 4 TIMES A DAY. CHILDREN UNDER 12 YEARS OF AGE: ASK A DOCTOR.

SPL UNCLASSIFIED SECTION

DO NOT USE IF GLUED CARTON AND FLAPS ARE OPEN OR IF THE TUBE SEAL IS BROKEN.

TUBE 1 OZ. (30G)

STORE AT 68-77° F (20-25° 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 letters "HPUS" indicate that the components in this product are offically monographed in the Homeopathic Pharmacopoeia of the United States.

Soothing Relief

Reduces Swelling

Plant Base Actives

Paraben Free

INACTIVE INGREDIENT

ALCOHOL, WHITE PETROLATUM USP

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, collinsonia canadensis root, hamamelis virginiana root bark/stem bark ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0220-9178
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK (UNII: T7S323PKJS) (HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK - UNII:T7S323PKJS)	HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK	1 [hp_X]
COLLINSONIA CANADENSIS ROOT (UNII: O2630F3XDR) (COLLINSONIA CANADENSIS ROOT - UNII:O2630F3XDR)	COLLINSONIA CANADENSIS ROOT	1 [hp_X]
HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ)	HORSE CHESTNUT	1 [hp_X]

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
ALCOHOL (UNII: 3K9958V90M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0220-9178-51	30 in 1 TUBE; 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(0220-9178)