FDA.reportPublic FDA data

H-Cold Sores Formula

Manufacturer
Healing Natural Oils LLC | King Bio, Inc.
Effective date
2024-12-11
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:29:31

Label at a glance#

ProductH-Cold Sores Formula
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, RANUNCULUS BULBOSUS
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 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,

Ranunculus bulbosus- 12C HPUS   

Purpose

OTC - PURPOSE SECTION

Calendula officinalis -12C HPUS  (for herpes, healing agent),

Ranunculus bulbosus -12C HPUS (herpetic eruptions)

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 (Cymbopogon martinii aerial parts,
Lavandula officinalis flower bud, Litsea cubeba seed,
Melaleuca alternifolia leaf-branch, Pelargonium graveolens whole
plant)

Indications:

INDICATIONS & USAGE SECTION

For the treatment of cold sore symptoms, such as fever blisters, soreness at blister site.

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 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 1042 N El Camino Real,

#B-426, Encinitas, CA 92024 USA

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healing Natural Oils

H-Cold Sores
Formula

Homeopathic

For External Use Only

127

11ml (0.37 fl. oz)
amoils.com

H-Cold Sores Formula label
H-Cold Sores Formula label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61077-127-11H-Cold Sores Formula11 mL in 1 BOTTLE, DROPPEROIL118
61077-127-33H-Cold Sores Formula33 mL in 1 BOTTLE, DROPPEROIL338

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61077-127H-COLD SORES FORMULA (CALENDULA OFFICINALIS, RANUNCULUS BULBOSUS) OIL [HEALING NATURAL OILS LLC]8Current NDC, Legacy NDC, 2 package rows20241213_425bc0e8-c884-40cc-90e9-490e50f733c3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ6
RANUNCULUS BULBOSUSACTIVE INGREDIENTAEQ8NXJ0MB6
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ6
RANUNCULUS BULBOSUSACTIVE MOIETYAEQ8NXJ0MB6
CYMBOPOGON MARTINI TOPINACTIVE INGREDIENT7K1N3UZ6DU6
LAVANDULA ANGUSTIFOLIA FLOWERINACTIVE INGREDIENT19AH1RAF4M6
LITSEA CUBEBA FRUITINACTIVE INGREDIENTR3617MQA5Z6
MELALEUCA ALTERNIFOLIA LEAFINACTIVE INGREDIENTG43C57162K6
PELARGONIUM GRAVEOLENS WHOLEINACTIVE INGREDIENT0E553RP62F6

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61077-12761077-127-11, 61077-127-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CYMBOPOGON MARTINI TOP7K1N3UZ6DUIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
LITSEA CUBEBA FRUITR3617MQA5ZIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
PELARGONIUM GRAVEOLENS WHOLE0E553RP62FIACT
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
RANUNCULUS BULBOSUSAEQ8NXJ0MBACTIB

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-Cold Sores FormulaCALENDULA OFFICINALIS, RANUNCULUS BULBOSUSHealing Natural Oils LLC425bc0e8-c884-40cc-90e9-490e50f733c32024-12-11WarningsExact identifier
ndc (package): 61077-127-33
ndc (package): 61077-127-11
ndc (product): 61077-127
ndc11 (package): 61077012733
ndc11 (package): 61077012711
spl id: 2906ca73-43de-2c24-e063-6294a90a7bf2
spl set id: 425bc0e8-c884-40cc-90e9-490e50f733c3

Reported adverse events (FAERS/openFDA)#

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