H-Acne 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-Acne Formula
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE
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,
Nux vomica -12C HPUS,
Silicea 12C HPUS

Purpose

OTC - PURPOSE SECTION

Calendula officinalis -12C HPUS (healing agent), 
Nux vomica-12C  HPUS  (acne,  skin red),
Silicea 12C HPUS  (for blotches on skin)

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,
Daucus carota seed,   Helichrysum  italicum  flower,
Lavandula  officinalis flower bud,  Melaleuca
alternifolia leaf-branch, Pelargonium
graveolens whole plant)

Indications:

INDICATIONS & USAGE SECTION

For the temporary relief of the symptoms of acne, blemishes and pimples.

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-Acne
Formula

Homeopathic

For External Use Only

020

11ml (0.37 fl. oz)
amoils.com

Acne LabelAcne Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61077-020-11H-Acne Formula11 mL in 1 BOTTLE, DROPPEROIL114
61077-020-33H-Acne Formula33 mL in 1 BOTTLE, DROPPEROIL334

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61077-020H-ACNE FORMULA (CALENDULA OFFICINALIS, NUX VOMICA, SILICEA) OIL [HEALING NATURAL OILS LLC]4Current NDC, Legacy NDC, 2 package rows20171227_fd9598ac-8f69-4fba-99c1-4234c8afcafd.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ3
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU43
STRYCHNOS NUX-VOMICA SEEDACTIVE INGREDIENT269XH139193
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ3
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU43
STRYCHNOS NUX-VOMICA SEEDACTIVE MOIETY269XH139193
CYMBOPOGON MARTINI TOPINACTIVE INGREDIENT7K1N3UZ6DU3
DAUCUS CAROTA SUBSP. SATIVUS SEEDINACTIVE INGREDIENT9M6AAX381U3
HELICHRYSUM ITALICUM FLOWERINACTIVE INGREDIENTP62Y550X243
LAVANDULA ANGUSTIFOLIA FLOWERINACTIVE INGREDIENT19AH1RAF4M3
MELALEUCA ALTERNIFOLIA LEAFINACTIVE INGREDIENTG43C57162K3
PELARGONIUM GRAVEOLENS WHOLEINACTIVE INGREDIENT0E553RP62F3

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61077-02061077-020-11, 61077-020-33

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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-Acne FormulaCALENDULA OFFICINALIS, NUX VOMICA, SILICEAHealing Natural Oils LLCfd9598ac-8f69-4fba-99c1-4234c8afcafd2017-12-27WarningsExact identifier
ndc (package): 61077-020-33
ndc (package): 61077-020-11
ndc (product): 61077-020
ndc11 (package): 61077002033
ndc11 (package): 61077002011
spl id: 8d32a590-f3d8-4237-b0dd-6a94389dc1d2
spl set id: fd9598ac-8f69-4fba-99c1-4234c8afcafd

Reported adverse events (FAERS/openFDA)#

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