FDA.reportPublic FDA data

H-Molluscum Formula

Manufacturer
Healing Natural Oils LLC | Apotheca Company
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:29:29

Label at a glance#

ProductH-Molluscum Formula
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, THUJA OCCIDENTALIS LEAFY TWIG
Label structure8 sections

Dosage and administration

Adults and children 4 years and over: Wash hands before and after use. Shake well and apply 1 or 2 drops to a cotton swab and dab to the bumps 3x daily. Do not oversaturate or exceed dosage.

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Calendula officinalis -12C HPUS,
Thuja occidentalis - 12C HPUS

Purpose

OTC - PURPOSE SECTION

Calendula officinalis -12C HPUS (healing agent), 
Thuja occidentalis  12C HPUS  (acts on skin, warts, tuburcles)

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

Essential Oil Blend (Boswellia carteri oleo-gum-resin, Citrus limon peel, Cupressus sempervirens leaves and twigs, Melaleuca alterniforlia leaf-branch, Thuja occidentalis leaf), Ethanol

Indications:

INDICATIONS & USAGE SECTION

For the treatment of the symptoms associated with molluscum such as bumps and papules.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children 4 years and over: Wash hands before and after use.
Shake well and apply 1 or 2 drops to a cotton swab and dab to the bumps 3x daily.
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 1042 N El Camino Real,

#B-426, Encinitas, CA 92024 USA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healing Natural Oils

H-Molluscum
Formula

Homeopathic

For External Use Only

026

11ml (0.37 fl. oz)
amoils.com

H-Molluscum Formula label
H-Molluscum Formula label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61077-026-11H-Molluscum Formula11 mL in 1 BOTTLE, DROPPEROIL113
61077-026-33H-Molluscum Formula33 mL in 1 BOTTLE, DROPPEROIL333

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61077-026H-MOLLUSCUM FORMULA (CALENDULA OFFICINALIS, THUJA OCCIDENTALIS) OIL [HEALING NATURAL OILS LLC]3Current NDC, Legacy NDC, 2 package rows20241213_0d253ded-3865-4e89-ad92-0a22204b792a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ1
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V93971
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ1
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V93971
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
CUPRESSUS SEMPERVIRENS LEAFY TWIGINACTIVE INGREDIENT7HB6L93P3U1
FRANKINCENSEINACTIVE INGREDIENTR9XLF1R1WM1
LEMON PEELINACTIVE INGREDIENT72O054U6281
MELALEUCA ALTERNIFOLIA LEAFINACTIVE INGREDIENTG43C57162K1
THUJA OCCIDENTALIS LEAFINACTIVE INGREDIENT0T0DQN87861

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61077-02661077-026-11, 61077-026-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
FRANKINCENSER9XLF1R1WMIACT
LEMON PEEL72O054U628IACT
CUPRESSUS SEMPERVIRENS LEAFY TWIG7HB6L93P3UIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
THUJA OCCIDENTALIS LEAF0T0DQN8786IACT
ALCOHOL3K9958V90MIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB

Source Document#

Source XML

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
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 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
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 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
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact 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
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii+route
33 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 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

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-Molluscum FormulaCALENDULA OFFICINALIS, THUJA OCCIDENTALISHealing Natural Oils LLC0d253ded-3865-4e89-ad92-0a22204b792a2024-12-11WarningsExact identifier
ndc (package): 61077-026-11
ndc (package): 61077-026-33
ndc (product): 61077-026
ndc11 (package): 61077002611
ndc11 (package): 61077002633
spl id: 290692c0-54dc-d401-e063-6294a90a705a
spl set id: 0d253ded-3865-4e89-ad92-0a22204b792a

Reported adverse events (FAERS/openFDA)#

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