FDA.reportPublic FDA data

Lipotox

Manufacturer
BioActive Nutritional, Inc. | Apotheca Company
Effective date
2023-09-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:22:13

Label at a glance#

ProductLipotox
Active ingredientSQUALENE, CHOLESTEROL, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALDEHYDE SOLUTION, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, ANHYDROUS TRISODIUM CITRATE, TITANIUM DIOXIDE, ZINC OXIDE, ARSENIC TRIOXIDE, LYCOPODIUM CLAVATUM SPORE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHOSPHORUS, ACETIC ACID, BENZOIC ACID, BENZYL ALCOHOL, BORIC ACID, CHLORINE, CORTISONE ACETATE, EUGENOL, ESTRONE, ISOPROPYL PALMITATE, LACTIC ACID, DL-, PETROLATUM, PHENYLBUTAZONE, LEAD, POTASSIUM SORBATE, RESORCINOL, SALICYLIC ACID, SORBITOL, STEARYL ALCOHOL, XYLITOL, CORTICOTROPIN
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Squalene 8X, Cholesterinum 12X, Estradiol 12X, Progesterone 12X, Aspartame 30X, Benzalkonium Chloride 30X, Formalinum 30X, Methylene Chloride 30X, Methylparaben 30X, Propylparaben 30X, Sodium Benzoate 30X, Sodium Citrate 30X, Titanium Dioxide 30X, Zincum Oxydatum 30X, Arsenicum Album 30X, Lycopodium Clavatum 30X, Nux Vomica 30X, Phosphoricum Acidum 30X, Phosphorus 30X, Aceticum Acidum 30X, 60X, 200X, Benzoicum Acidum 30X, 60X, 200X, Benzyl Alcohol 30X, 60X, 200X, Boricum Acidum 30X, 60X, 200X, Chlorinum 30X, 60X, 200X, Cortisone Aceticum 30X, 60X, 200X, Eugenol 30X, 60X, 200X, Folliculinum 30X, 60X, 200X, Isopropyl Palmitate 30X, 60X, 200X, Lacticum Acidum 30X, 60X, 200X, Petroleum Jelly 30X, 60X, 200X, Phenyl Butazone 30X, 60X, 200X, Plumbum Metallicum 30X, 60X, 200X, Potassium Sorbate 30X, 60X, 200X, Resorcinum 30X, 60X, 200X, Salicylicum Acidum 30X, 60X, 200X, Sorbitol 30X, 60X, 200X, Stearyl Alcohol 30X, 60X, 200X, Xylitol 30X, 60X, 200X, Adrenocorticotrophin 30C, 60C, 200C.

PURPOSE:

OTC - PURPOSE SECTION

For temporary relief of exhaustion & restlessness, metallic taste & dyspepsia & menstrual pain.

WARNINGS:

WARNINGS SECTION

If pregnant or breast-feeding, ask a health care professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if tamper evident seal is broken or missing.
Store in cool, dry place.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of exhaustion & restlessness, metallic taste & dyspepsia & menstrual pain.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Borage Oil, Castor Oil, Demineralized Water, 25% Ethanol.

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

bioactivenutritional.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BIOActiveNutritional

LIPOTOX

HOMEOPATHIC

1 FL OZ (30 ml)

LIPOTOXLIPOTOX

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
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3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
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d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0636-1Lipotox30 mL in 1 BOTTLE, DISPENSINGLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0636LIPOTOX (SQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,) LIQUID [BIOACTIVE NUTRITIONAL, INC.]1Current NDC, 1 package rows20230910_a1538692-ca00-4e52-9b7e-409767ee27e1.zip

Products#

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

DailyMed product names page 1 of 2 · 51 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43857-063643857-0636-1

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Name, UNII, Kind table
NameUNIIKind
SQUALENE7QWM220FJHACTIB
CHOLESTEROL97C5T2UQ7JACTIB
ESTRADIOL4TI98Z838EACTIB
PROGESTERONE4G7DS2Q64YACTIB
ASPARTAMEZ0H242BBR1ACTIB
BENZALKONIUM CHLORIDEF5UM2KM3W7ACTIB
FORMALDEHYDE SOLUTIONT0H3L6C7I5ACTIB
METHYLENE CHLORIDE588X2YUY0AACTIB
METHYLPARABENA2I8C7HI9TACTIB
PROPYLPARABENZ8IX2SC1OHACTIB
SODIUM BENZOATEOJ245FE5EUACTIB
ANHYDROUS TRISODIUM CITRATERS7A450LGAACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
ARSENIC TRIOXIDES7V92P67HOACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
PHOSPHORUS27YLU75U4WACTIB
ACETIC ACIDQ40Q9N063PACTIB
BENZOIC ACID8SKN0B0MIMACTIB
BENZYL ALCOHOLLKG8494WBHACTIB
BORIC ACIDR57ZHV85D4ACTIB
CHLORINE4R7X1O2820ACTIB
CORTISONE ACETATE883WKN7W8XACTIB
EUGENOL3T8H1794QWACTIB
ESTRONE2DI9HA706AACTIB
ISOPROPYL PALMITATE8CRQ2TH63MACTIB
LACTIC ACID, DL-3B8D35Y7S4ACTIB
PETROLATUM4T6H12BN9UACTIB
PHENYLBUTAZONEGN5P7K3T8SACTIB
LEAD2P299V784PACTIB
POTASSIUM SORBATE1VPU26JZZ4ACTIB
RESORCINOLYUL4LO94HKACTIB
SALICYLIC ACIDO414PZ4LPZACTIB
SORBITOL506T60A25RACTIB
STEARYL ALCOHOL2KR89I4H1YACTIB
XYLITOLVCQ006KQ1EACTIB
CORTICOTROPINK0U68Q2TXAACTIB
BORAGE OILF8XAG1755SIACT

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
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
ndc (package): 43857-0636-1
ndc (product): 43857-0636
ndc11 (package): 43857063601
spl id: c6b2d570-cc46-41fc-97f8-2734223ad76e
spl set id: a1538692-ca00-4e52-9b7e-409767ee27e1

Reported adverse events (FAERS/openFDA)#

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