H-Fissures Formula

Manufacturer
Healing Natural Oils LLC | King Bio, Inc.
Effective date
2017-12-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:09:06

Label at a glance#

ProductH-Fissures Formula
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, MATRICARIA RECUTITA
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   
Chamomilla - 6C HPUS

Purpose

OTC - PURPOSE SECTION

Calendula officinalis - 12C HPUS (healing agent),
Chamomilla - 6C HPUS (soreness of anus, painful fissures).

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, Lavandula officinalis flower
bud, Matricaria recutita flower)

Indications:

INDICATIONS & USAGE SECTION

For the temporary relief of anal fissure 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

If pregnant or breastfeeding consult a doctor before use.

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-Fissures

Formula

Homeopathic

For External Use Only

036

11ml (0.37 fl. oz)
amoils.com

Fissures LabelFissures Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61077-036-11H-Fissures Formula11 mL in 1 BOTTLE, DROPPEROIL114
61077-036-33H-Fissures Formula33 mL in 1 BOTTLE, DROPPEROIL334

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61077-036H-FISSURES FORMULA (CALENDULA OFFICINALIS, CHAMOMILLA) OIL [HEALING NATURAL OILS LLC]4Current NDC, Legacy NDC, 2 package rows20171227_aa2b25cc-5bf3-4aee-951f-497b8ae69f07.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ3
MATRICARIA RECUTITAACTIVE INGREDIENTG0R4UBI2ZZ3
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ3
MATRICARIA RECUTITAACTIVE MOIETYG0R4UBI2ZZ3
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X3
EUROPEAN HAZELNUT OILINACTIVE INGREDIENT8RQ2839AVG3
HELICHRYSUM ITALICUM FLOWERINACTIVE INGREDIENTP62Y550X243
LAVANDULA ANGUSTIFOLIA FLOWERINACTIVE INGREDIENT19AH1RAF4M3

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
61077-03661077-036-11, 61077-036-33

Ingredients#

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

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

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
H-Fissures FormulaCALENDULA OFFICINALIS, CHAMOMILLAHealing Natural Oils LLCaa2b25cc-5bf3-4aee-951f-497b8ae69f072017-12-27WarningsExact identifier
ndc (package): 61077-036-11
ndc (package): 61077-036-33
ndc (product): 61077-036
ndc11 (package): 61077003611
ndc11 (package): 61077003633
spl id: efb6fcab-fd09-4d35-ac13-909cb0d9a9d8
spl set id: aa2b25cc-5bf3-4aee-951f-497b8ae69f07

Reported adverse events (FAERS/openFDA)#

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