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 directly to the moles 3x daily. Do not oversaturate or exceed dosage.
H-Moles 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 02:09:08
Label at a glance#
ProductH-Moles Formula
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, PHYTOLACCA AMERICANA ROOT, THUJA OCCIDENTALIS LEAFY TWIG
Label structure8 sections
Label contents#
Full prescribing information#
Active Ingredients:
Calendula officinalis - 12C HPUS Phytolacca decandra - 12C HPUS |
Purpose
| Calendula officinalis -12C HPUS (healing agent), Phytolacca decandra - 12C HPUS (for moles), Thuja occidentalis - 12C HPUS (acts on skin, moles) The letters ‘HPUS’ indicate that the components in this product are officially |
Inactive Ingredients:
Essential Oil Blend (Lavandula officinalis flower bud, Melaleuca
alternifolia leaf-branch, Melissa officinalis blossoms and whole plant,
Thuja occidentalis leaf), Sesamum Indicum seed oil
Indications:
Symptomatic treatment of benign skin moles
Directions:
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 directly to the moles 3x daily.
Do not oversaturate or exceed dosage.
Warnings:
For external use only.
Only use on benign skin moles.
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-Moles
Formula
Homeopathic
For External Use Only
125
11ml (0.37 fl. oz)
amoils.com
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61077-125-11 | H-Moles Formula | 11 mL in 1 BOTTLE, DROPPER | OIL | 11 | 4 | |
| 61077-125-33 | H-Moles Formula | 33 mL in 1 BOTTLE, DROPPER | OIL | 33 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61077-125 | H-MOLES FORMULA (CALENDULA OFFICINALIS, PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS) OIL [HEALING NATURAL OILS LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20171228_e02194ec-cfa7-4f36-be02-a53b1e80a235.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| CALENDULA OFFICINALIS FLOWERING TOP | ACTIVE INGREDIENT | 18E7415PXQ | 3 | |
| PHYTOLACCA AMERICANA ROOT | ACTIVE INGREDIENT | 11E6VI8VEG | 3 | |
| THUJA OCCIDENTALIS LEAFY TWIG | ACTIVE INGREDIENT | 1NT28V9397 | 3 | |
| CALENDULA OFFICINALIS FLOWERING TOP | ACTIVE MOIETY | 18E7415PXQ | 3 | |
| PHYTOLACCA AMERICANA ROOT | ACTIVE MOIETY | 11E6VI8VEG | 3 | |
| THUJA OCCIDENTALIS LEAFY TWIG | ACTIVE MOIETY | 1NT28V9397 | 3 | |
| LAVANDULA ANGUSTIFOLIA FLOWERING TOP | INACTIVE INGREDIENT | 9YT4B71U8P | 3 | |
| MELALEUCA ALTERNIFOLIA LEAF | INACTIVE INGREDIENT | G43C57162K | 3 | |
| MELISSA OFFICINALIS | INACTIVE INGREDIENT | YF70189L0N | 3 | |
| SESAME OIL | INACTIVE INGREDIENT | QX10HYY4QV | 3 | |
| THUJA OCCIDENTALIS LEAF | INACTIVE INGREDIENT | 0T0DQN8786 | 3 |
Products#
Every source-derived product name is available through these pages.
- H-Moles Formula
- calendula officinalis, phytolacca decandra, thuja occidentalis
- CALENDULA OFFICINALIS FLOWERING TOP
- PHYTOLACCA AMERICANA ROOT
- LAVANDULA ANGUSTIFOLIA FLOWERING TOP
- MELALEUCA ALTERNIFOLIA LEAF
- MELISSA OFFICINALIS
- THUJA OCCIDENTALIS LEAF
- THUJA OCCIDENTALIS LEAFY TWIG
- SESAME OIL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 61077-125 | 61077-125-11, 61077-125-33 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SESAME OIL | SESAME OIL | QX10HYY4QV | INJECTION / INTRAMUSCULAR | 70 %v/v | ||
| SESAME OIL | SESAME OIL | QX10HYY4QV | CAPSULE / ORAL | 2325 mg | ||
| SESAME OIL | SESAME OIL | QX10HYY4QV | CAPSULE / ORAL | 2325 mg | ||
| SESAME OIL | SESAME OIL | QX10HYY4QV | INJECTION / INTRAMUSCULAR | 70 %v/v | ||
| SESAME OIL | SESAME OIL | QX10HYY4QV | CAPSULE / ORAL | 2325 mg | ||
| SESAME OIL | SESAME OIL | QX10HYY4QV | INJECTION / INTRAMUSCULAR | 70 %v/v |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| H-Moles Formula | CALENDULA OFFICINALIS, PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS | Healing Natural Oils LLC | e02194ec-cfa7-4f36-be02-a53b1e80a235 | 2017-12-27 | Warnings | 61077-125-11 61077-125-33 61077-125 61077012511 61077012533 70226e31-d06a-4e8f-b9ba-b0742f63ee46 e02194ec-cfa7-4f36-be02-a53b1e80a235 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.