FDA.reportPublic FDA data

H-BI Hemorrhoids Formula

Manufacturer
Healing Natural Oils LLC | King Bio Inc
Effective date
2017-12-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:09:00

Label at a glance#

ProductH-BI Hemorrhoids Formula
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK
Label structure8 sections

Dosage and administration

Adults and Children 4 yrs and over: Wash hands before and after use. Shake well and apply 1 or 2 drops to a cotton swab or your finger and apply directly to the affected area 3x per day. Do not oversaturate or exceed dosage.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Calendula officinalis -12C HPUS

Hamamelis virginiana - 6C HPUS 

Purpose

OTC - PURPOSE SECTION

Calendula officinalis - 12C HPUS (healing agent),

Hamamelis virginiana - 6C HPUS (anus raw, bleeding).



The letters ‘HPUS’ indicate that the components in this product are officially
monographed in the Homoeopathic Pharmacopoeia of the United States

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Corylus avellana nut oil, Essential Oil Blend (Helichrysum italicum flower,

Matricaria recutita flower, Pelargonium graveolens whole plant)

Indications:

INDICATIONS & USAGE SECTION

For the temporary relief of hemorrhoid symptoms such as burning,
soreness and minor bleeding

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and Children 4 yrs and over: Wash hands before and after use.
Shake well and apply 1 or 2 drops to a cotton swab or your finger and apply directly to the affected area 3x per day.
Do not oversaturate or exceed dosage.

Warnings:

WARNINGS SECTION

For external use only.

Perform skin test prior to initial use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Do not use if pregnant or breastfeeding.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER SAFETY INFORMATION

Keep away from eyes and mucous membranes. If swallowed get medical help or contact a Poison Control
Center right away.

OTC - STOP USE SECTION

Discontinue use if irritation occurs.

OTC - ASK DOCTOR SECTION

Consult a doctor if symptoms worsen after 7 days.

DESCRIPTION SECTION

Dist. by Healing Natural Oils 3830 Valley Ctr Dr, #705-526, San Diego, CA 92130, USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healing Natural Oils

H-BI Hemorrhoids
Formula

Homeopathic

For External Use Only

005

11ml (0.37 fl. oz)
amoils.com

BI Hemorrhoids Label 11BI Hemorrhoids Label 11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61077-005-11H-BI Hemorrhoids Formula11 mL in 1 BOTTLE, DROPPEROIL112
61077-005-33H-BI Hemorrhoids Formula33 mL in 1 BOTTLE, DROPPEROIL332

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61077-005H-BI HEMORRHOIDS FORMULA (CALENDULA OFFICINALLIS, HAMAMELIS VIRGINIANA) OIL [HEALING NATURAL OILS LLC]2Current NDC, Legacy NDC, 2 package rows20171211_a6f59c34-e252-4458-8ce4-01e2d3028aa8.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE INGREDIENTT7S323PKJS1
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ1
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKACTIVE MOIETYT7S323PKJS1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X1
EUROPEAN HAZELNUT OILINACTIVE INGREDIENT8RQ2839AVG1
HELICHRYSUM ITALICUM FLOWERINACTIVE INGREDIENTP62Y550X241
PELARGONIUM GRAVEOLENS WHOLEINACTIVE INGREDIENT0E553RP62F1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61077-00561077-005-11, 61077-005-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSACTIB
EUROPEAN HAZELNUT OIL8RQ2839AVGIACT
HELICHRYSUM ITALICUM FLOWERP62Y550X24IACT
CHAMOMILEFGL3685T2XIACT
PELARGONIUM GRAVEOLENS WHOLE0E553RP62FIACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 33 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
33 equally ranked IID candidates

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
H-BI Hemorrhoids FormulaCALENDULA OFFICINALLIS, HAMAMELIS VIRGINIANAHealing Natural Oils LLCa6f59c34-e252-4458-8ce4-01e2d3028aa82017-12-11WarningsExact identifier
ndc (package): 61077-005-11
ndc (package): 61077-005-33
ndc (product): 61077-005
ndc11 (package): 61077000533
ndc11 (package): 61077000511
spl id: b6a0fff6-0ded-49d8-be48-a2a2d17bcd53
spl set id: a6f59c34-e252-4458-8ce4-01e2d3028aa8

Reported adverse events (FAERS/openFDA)#

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