NDC 0220-9180 Hemcalm

Horse Chestnut, Hamamelis Virginiana Root Bark/stem Bark, Strychnos Nux-vomica Seed

NDC Product Code 0220-9180

NDC CODE: 0220-9180

Proprietary Name: Hemcalm What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Horse Chestnut, Hamamelis Virginiana Root Bark/stem Bark, Strychnos Nux-vomica Seed What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325)
Shape: ROUND (C48348)
Size(s):
9 MM
Imprint(s):
BOIRON
Score: 1

NDC Code Structure

NDC 0220-9180-04

Package Description: 60 BLISTER PACK in 1 CARTON > 60 TABLET in 1 BLISTER PACK

NDC Product Information

Hemcalm with NDC 0220-9180 is a a human over the counter drug product labeled by Boiron. The generic name of Hemcalm is horse chestnut, hamamelis virginiana root bark/stem bark, strychnos nux-vomica seed. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Boiron

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Hemcalm Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 6 [hp_X]/1
  • STRYCHNOS NUX-VOMICA SEED 12 [hp_X]/1
  • HORSE CHESTNUT 6 [hp_X]/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • CROSCARMELLOSE (UNII: 029TFK992N)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Boiron
Labeler Code: 0220
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-01-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Hemcalm Product Label Images

Hemcalm Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

AESCULUS HIPPOCASTANUM 6X HPUS (0.83MG), HAMAMELIS VIRGINANA 6X HPUS (0.83MB) NUX VOMICA 12X HPUS (0.83MG)**

Otc - Purpose

AESCULUS HIPPOCASTANUM 6X HPUS REDUCES SWELLING AND RELIEVES STINGING PAIN ASSOCIATED WITH EXTERNAL HEMORRHOIDS*HAMAMELIS VIRGINANA 6X HPUS RELIEVES BURNING, ITCHING, AND DISCOMFORT ASSOCIATED WITH HEMMORRHOIDS*NUX VOMICA 12X HPUS RELIEVES PAINFUL HEMORRHOIDS ASSOCIATED WITH OVEREATING AND SEDENTARY LIFESTYLES*(CONTAINS LESS THA 10-13 MG ALKALOIDS)

Indications & Usage

TEMPORARILY RELIEVES SYMPTOMS OF HEMMORRHOIDS SUCH AS: BURNING, ITCHING, SWELLING, PAIN, DISCOMFORTHELPS SHRINK SWOLLEN HEMORRHOIDSRELIEVES HEMORRHOID SYMPTOMS FOLLOWING CHILDBIRTH

Otc - Ask Doctor

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. IN CASE OF ACCIDENTAL OVERDOSE, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Dosage & Administration

ADULTS AND CHILDREN 12 YEARS OF AGE AND OLDER: AT THE ONSET OF SYMPTOMS, ALLOW 2 TABLETS TO DISSOLVE UNDER THE TONGUE EVERY 2 HOURS, UP TO 6 TIMES A DAY.CHILDREN UNDER 6 YEARS OF AGE: ASK A DOCTOR.

Other

DO NOT USE IF GLUED CARTON AND FLAPS ARE OPEN OR IF THE BLISTER SEAL IS BROKENCONTAINS 60 TABLETSSTORE BELOW 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.

Inactive Ingredient

LACTOSE, CROSCARMELLOSE SODIUM, MAGNESIUM STEARATE

Otc - Questions

1-800-BOIRON-1 (1-800-264-7661),

BoironUSA.com Info@boiron.com

Distributed by Boiron, Inc. Newtown Square, PA 19073

* Please review the disclaimer below.