DRUG FACTS:

Manufacturer: Apotheca Company
Effective date: 2026-05-19
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-06-01 02:38:40

Label at a glance#

ProductH Acne Formula

Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, STRYCHNOS NUX-VOMICA SEED, SILICON DIOXIDE

Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS: alendula officinalis 12C HPUS, Nux vomica 12C HPUS, Silicea 12C HPUS.

INDICATIONS:

OTC - PURPOSE SECTION

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

WARNINGS SECTION

WARNINGS: For external use only.

Perform skin test prior to initial use.

Do not use if pregnant or breastfeeding.

Keep out of reach of children. Keep away from eyes and mucous membranes. If swallowed get medical help or contact a Poison Control Center right away.

Discontinue use if irritations occurs.

Consult a doctor if symptoms worsen after 7 days.

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: 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.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Cymbopogon martinii aerial parts, Daucus carota seed, Helichrysum italicum flower, Lavandula officinalis flower bud, Melaleuca alternifolia leaf-branch, Pelargonium graveolens whole plant, Ethanol.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN. Keep away from eyes and mucous membranes. If swallowed get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

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

OTC - QUESTIONS SECTION

Dist. by Healing Natural Oils

1042 N El Camino Real #B-426

Encinitas, CA 92024 USA

The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Healing Natural Oils

H Acne Formula

Homeopathic

For External Use Only

045

33ml (1.12 fl. oz)

H-Acne Formula

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
57520-1111-1	2020-01-31	C162847	48780-1	9d75b9d0-efad-f424-e053-dadaa90a57ce	DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
57520-1111-1	H Acne Formula	33 mL in 1 BOTTLE, DROPPER	OIL	33		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CALENDULA OFFICINALIS FLOWERING TOP	ACTIVE INGREDIENT	18E7415PXQ	1
SILICON DIOXIDE	ACTIVE INGREDIENT	ETJ7Z6XBU4	1
STRYCHNOS NUX-VOMICA SEED	ACTIVE INGREDIENT	269XH13919	1
CALENDULA OFFICINALIS FLOWERING TOP	ACTIVE MOIETY	18E7415PXQ	1
SILICON DIOXIDE	ACTIVE MOIETY	ETJ7Z6XBU4	1
STRYCHNOS NUX-VOMICA SEED	ACTIVE MOIETY	269XH13919	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	1
CARROT SEED OIL	INACTIVE INGREDIENT	595AO13F11	1
GERANIUM OIL, ALGERIAN TYPE	INACTIVE INGREDIENT	5Q1I94P4WG	1
HELICHRYSUM ITALICUM FLOWER OIL	INACTIVE INGREDIENT	O97ZV7726K	1
LAVENDER OIL	INACTIVE INGREDIENT	ZBP1YXW0H8	1
PALMAROSA OIL	INACTIVE INGREDIENT	0J3G3O53ST	1
TEA TREE OIL	INACTIVE INGREDIENT	VIF565UC2G	1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

H Acne Formula
Calendula officinalis, Nux vomica, Silicea,
CALENDULA OFFICINALIS FLOWERING TOP
STRYCHNOS NUX-VOMICA SEED
SILICON DIOXIDE
TEA TREE OIL
PALMAROSA OIL
LAVENDER OIL
GERANIUM OIL, ALGERIAN TYPE
CARROT SEED OIL
HELICHRYSUM ITALICUM FLOWER OIL
ALCOHOL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57520-1111	57520-1111-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CALENDULA OFFICINALIS FLOWERING TOP	18E7415PXQ	ACTIB
STRYCHNOS NUX-VOMICA SEED	269XH13919	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	ACTIB
TEA TREE OIL	VIF565UC2G	IACT
PALMAROSA OIL	0J3G3O53ST	IACT
LAVENDER OIL	ZBP1YXW0H8	IACT
GERANIUM OIL, ALGERIAN TYPE	5Q1I94P4WG	IACT
CARROT SEED OIL	595AO13F11	IACT
HELICHRYSUM ITALICUM FLOWER OIL	O97ZV7726K	IACT
ALCOHOL	3K9958V90M	IACT

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 2 · 61 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / RESPIRATORY (INHALATION)		26664 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / ORAL	198 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVENOUS	92 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY, METERED / SUBLINGUAL		29 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / ORAL	150.68 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CONCENTRATE / BUCCAL	679 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, EMULSION / INTRAVENOUS		520 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	ELIXIR / ORAL		13675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAVENOUS		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / DENTAL	12.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / SUBCUTANEOUS		149 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / SUBCUTANEOUS	6.1 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	PASTE / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL, METERED / TRANSDERMAL		3675 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAMUSCULAR		1491 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / SUBLINGUAL		397 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / RECTAL		898 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TOPICAL		3633 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / TRANSDERMAL	90 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	POWDER, FOR SOLUTION / TOPICAL	40 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	LIQUID / INTRAMUSCULAR		400 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
LAVENDER OIL	LAVENDER OIL	ZBP1YXW0H8	GEL / TOPICAL	0.1 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
LAVENDER OIL	LAVENDER OIL	ZBP1YXW0H8	INHALANT / NASAL	NA		Exact identifier — unii candidate 2 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / TOPICAL		2445 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVENOUS		99 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / INTRAVESICAL		7892 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	CAPSULE, EXTENDED RELEASE / ORAL		8 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SYRUP / ORAL		21000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, FOAM / TOPICAL		4504 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / ORAL		681 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SUSPENSION / RECTAL	0.35 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / RESPIRATORY (INHALATION)	0.08 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	JELLY / VAGINAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
ALCOHOL	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
70548b27-1925-44c6-8999-f5f47984a6bd			cb16364f-446f-45ec-9232-4b7b0b98a88d	2026-05-19	Warnings	Exact identifier spl id: 70548b27-1925-44c6-8999-f5f47984a6bd spl set id: cb16364f-446f-45ec-9232-4b7b0b98a88d

Reported adverse events (FAERS/openFDA)#

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