FDA.reportPublic FDA data

Self-Abuse

Manufacturer
King Bio Inc.
Effective date
2016-11-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:18

Label at a glance#

ProductSelf-Abuse
Active ingredientAMANITA MUSCARIA FRUITING BODY, ALOE, GOLD, CARBON DISULFIDE, MATRICARIA RECUTITA, BLACK COHOSH, ILEX AQUIFOLIUM FLOWERING TOP, LILIUM LANCIFOLIUM WHOLE FLOWERING, MALUS DOMESTICA FLOWER, ACHILLEA MILLEFOLIUM, SODIUM CARBONATE, PINUS SYLVESTRIS FLOWERING TOP, DATURA STRAMONIUM, LYCOSA TARANTULA
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients:​ Agaricus muscarius, Aloe, Aurum metallicum, Carboneum sulphuratum, Chamomilla, Cimicifuga racemosa, Ilex aquifolium, flos, Lilium tigrinum, Malus pumila, flos, Millefolium, Natrum carbonicum, Pinus sylvestris, flos, Stramonium, Tarentula hispanica. Equal volumes of each ingredient in 10X, 30X, 100X, 1LM, 2LM, 3LM, 5LM potencies.

INDICATIONS & USAGE SECTION

Uses a natural aid for: internalized anger, self-contempt and blame, dissatisfaction with life, violent thoughts or actions, depression, self-inflicted violence.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, citric acid and potassium sorbate.

WARNINGS SECTION

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults: 3 sprays 3 times per day
  • Children 2-12 years: 2 sprays 3 times per day.
  • Use additionally as needed, up to 6 times per day.

OTHER SAFETY INFORMATION

Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.

OTC - PURPOSE SECTION

Uses a natural aid for:

  • internalized anger
  • self-contempt and blame
  • dissatisfaction with life
  • violent thoughts or actions
  • depression
  • self-inflicted violence

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57955-1071-22020-01-31C16284748780-19d75b9cf-de77-f424-e053-dadaa90a57ceSelf-Abuse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57955-1071-2Self-Abuse59 mL in 1 BOTTLE, SPRAYLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57955-1071SELF-ABUSE (AGARICUS MUSCARIUS, ALOE, AURUM METALLICUM, CARBONEUM SULPHURATUM, CHAMOMILLA, CIMICIFUGA RACEMOSA, ILEX AQUIFOLIUM, FLOS, LILIUM TIGRINUM, MALUS PUMILA, FLOS, MILLEFOLIUM, NATRUM CARBONICUM, PINUS SYLVESTRIS, FLOS, STRAMONIUM, TARENTULA HISPANICA) LIQUID [KING BIO INC.]1Legacy NDC, 1 package rows20161115_5fbd4e24-9cda-4b09-8bca-3db804e5f7cd.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57955-107157955-1071-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMANITA MUSCARIA FRUITING BODYDIF093I037ACTIB
ALOEV5VD430YW9ACTIB
GOLD79Y1949PYOACTIB
CARBON DISULFIDES54S8B99E8ACTIB
MATRICARIA RECUTITAG0R4UBI2ZZACTIB
BLACK COHOSHK73E24S6X9ACTIB
ILEX AQUIFOLIUM FLOWERING TOP5ENR9SAN1WACTIB
LILIUM LANCIFOLIUM WHOLE FLOWERINGX67Z2963PIACTIB
MALUS DOMESTICA FLOWEREF626V855KACTIB
ACHILLEA MILLEFOLIUM2FXJ6SW4PKACTIB
SODIUM CARBONATE45P3261C7TACTIB
PINUS SYLVESTRIS FLOWERING TOP2HEM73YI9IACTIB
DATURA STRAMONIUMG6W4F0V8Z3ACTIB
LYCOSA TARANTULA86M454L2TTACTIB
WATER059QF0KO0RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

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
d9987a96-8ae7-4852-b1c4-fcac32a8a7a85fbd4e24-9cda-4b09-8bca-3db804e5f7cd2016-11-15WarningsExact identifier
spl id: d9987a96-8ae7-4852-b1c4-fcac32a8a7a8
spl set id: 5fbd4e24-9cda-4b09-8bca-3db804e5f7cd

Reported adverse events (FAERS/openFDA)#

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