FDA.reportPublic FDA data

Acne

Manufacturer
Biovea | Apotheca Company
Effective date
2022-03-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:06:42

Label at a glance#

ProductAcne
Active ingredientBACILLUS ANTHRACIS IMMUNOSERUM RABBIT, ANTIMONY TRISULFIDE, CENTELLA ASIATICA, JUGLANS REGIA FRUIT RIND, IMMATURE, JUGLANS REGIA LEAF, POTASSIUM BROMIDE, LEDUM PALUSTRE TWIG, SODIUM SULFATE, RANCID BEEF, RADIUM BROMIDE, SANGUINARIA CANADENSIS ROOT, SULFUR IODIDE, THUJA OCCIDENTALIS LEAFY TWIG, URTICA URENS
Label structure9 sections

Dosage and administration

Adults & children over 12. Spray twice under the tongue 3 times per day. Children 12 & under. Consult a doctor prior to use.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Anthracinum 200C, Antimonium Crudum 30C, Hydrocotyle Asiatica 30C, Juglans Regia 6X, Kali Bromatum 30C, Ledum Palustre 6X, Natrum Sulphuricum 200C, Pyrogenium 30C, Radium Bromatum 200C, Sanguinaria Canadensis 3X, Sulphur Iodatum 200C, Thuja Occidentalis 200C, Urtica Urens 3X.

INDICATIONS:

OTC - PURPOSE SECTION

Advanced homeopathic oral spray for the temporary relief of pimples, blemishes, redness and inflammation associated with acne.†

†These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

WARNINGS:

WARNINGS SECTION

If symptoms persist, consult a doctor.

If pregnant or breast feeding, ask a doctor before use.

Keep out of reach of children. In case of accidental overdose, get medical help or call a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental overdose, get medical help or call a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults & children over 12. Spray twice under the tongue 3 times per day.

Children 12 & under. Consult a doctor prior to use.

INDICATIONS:

INDICATIONS & USAGE SECTION

Advanced homeopathic oral spray for the temporary relief of pimples, blemishes, redness and inflammation associated with acne.†

†These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Organic alcohol 20% v/v, purified water.

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by: BIOVEA

Dallas, TX 75202

1-800-961-4750

www.biovea.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC# 69607-0012-1

BIOVEA

HOMEOPATHICS

Acne

Homeopathic

1 FL. OZ. (30ml)

SKIN CARE

AcneAcne

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69607-0012-12022-03-09C16284748780-19d75b9d0-20f8-f424-e053-dadaa90a57ceDRUG FACTS:
69607-0012-12020-01-31C16284748780-19d75b9d0-20f8-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ANTIMONY TRISULFIDEACTIVE INGREDIENTF79059A38U1
BACILLUS ANTHRACIS IMMUNOSERUM RABBITACTIVE INGREDIENT41LZ22DD4N1
CENTELLA ASIATICAACTIVE INGREDIENT7M867G6T1U1
JUGLANS REGIA FRUIT RIND, IMMATUREACTIVE INGREDIENTZPS7Q5U53K1
JUGLANS REGIA LEAFACTIVE INGREDIENT85HKB871051
LEDUM PALUSTRE TWIGACTIVE INGREDIENT877L01IZ0P1
POTASSIUM BROMIDEACTIVE INGREDIENTOSD78555ZM1
RADIUM BROMIDEACTIVE INGREDIENTR74O7T85691
RANCID BEEFACTIVE INGREDIENT29SUH5R3HU1
SANGUINARIA CANADENSIS ROOTACTIVE INGREDIENTN9288CD5081
SODIUM SULFATEACTIVE INGREDIENT0YPR65R21J1
SULFUR IODIDEACTIVE INGREDIENTL6L8KA2AA01
THUJA OCCIDENTALIS LEAFY TWIGACTIVE INGREDIENT1NT28V93971
URTICA URENSACTIVE INGREDIENTIHN2NQ5OF91
ANTIMONY TRISULFIDEACTIVE MOIETYF79059A38U1
BACILLUS ANTHRACIS IMMUNOSERUM RABBITACTIVE MOIETY41LZ22DD4N1
BROMIDE IONACTIVE MOIETY952902IX061
CENTELLA ASIATICAACTIVE MOIETY7M867G6T1U1
JUGLANS REGIA FRUIT RIND, IMMATUREACTIVE MOIETYZPS7Q5U53K1
JUGLANS REGIA LEAFACTIVE MOIETY85HKB871051
LEDUM PALUSTRE TWIGACTIVE MOIETY877L01IZ0P1
RADIUM CATIONACTIVE MOIETY05456MVL7T1
RANCID BEEFACTIVE MOIETY29SUH5R3HU1
SANGUINARIA CANADENSIS ROOTACTIVE MOIETYN9288CD5081
SODIUM SULFATE ANHYDROUSACTIVE MOIETY36KCS0R7501
SULFUR IODIDEACTIVE MOIETYL6L8KA2AA01
THUJA OCCIDENTALIS LEAFY TWIGACTIVE MOIETY1NT28V93971
URTICA URENSACTIVE MOIETYIHN2NQ5OF91
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69607-001269607-0012-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT41LZ22DD4NACTIB
ANTIMONY TRISULFIDEF79059A38UACTIB
CENTELLA ASIATICA7M867G6T1UACTIB
JUGLANS REGIA FRUIT RIND, IMMATUREZPS7Q5U53KACTIB
JUGLANS REGIA LEAF85HKB87105ACTIB
POTASSIUM BROMIDEOSD78555ZMACTIB
LEDUM PALUSTRE TWIG877L01IZ0PACTIB
SODIUM SULFATE0YPR65R21JACTIB
RANCID BEEF29SUH5R3HUACTIB
RADIUM BROMIDER74O7T8569ACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB
SULFUR IODIDEL6L8KA2AA0ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
URTICA URENSIHN2NQ5OF9ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0c828b12-561c-4a89-a126-49873e0918b5e6efc81c-9f22-42a6-ba3f-ec09d1920c192022-03-09WarningsExact identifier
spl id: 0c828b12-561c-4a89-a126-49873e0918b5
spl set id: e6efc81c-9f22-42a6-ba3f-ec09d1920c19

Reported adverse events (FAERS/openFDA)#

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