LIPOTOX- squalene, cholesterinum, estradiol, progesterone, aspartame, benzalkonium chloride, formalinum, methylene chloride, methyl paraben, propyl paraben, sodium benzoate, sodium citrate, titanium dioxide, zincum oxydatum, arsenicum album, lycopodium clavatum, nux vomica, phosphoricum acidum, phosphorus, aceticum acidum, adrenocorticotrophin, benzoicum acidum, benzyl alcohol, boricum acidum, chlorinum, cortisone aceticum, eugenol, folliculinum, isopropyl palmitate, lacticum acidum, petroleum jelly liquid 
BioActive Nutritional, Inc.

Disclaimer: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

----------

Drug Facts:

ACTIVE INGREDIENTS:

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, Adrenocorticotrophin 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.

INDICATIONS:

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

WARNINGS:

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:

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

DIRECTIONS:

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

INDICATIONS:

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

INACTIVE INGREDIENTS:

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

QUESTIONS:

Distributed by:

BIOACTIVE NUTRITIONAL

Melbourne, FL 32935

For Nutritional Information write:

BioActive Nutritional, Inc.

1803 N. Wickham Rd.

Melbourne, FL 32935

*For a complete list of Addisodes and Chemical Isodes contact BioActive Nutritional, Inc.

PACKAGE LABEL DISPLAY:

BIOActive Nutritional

LIPOTOX

HOMEOPATHIC

1 FL OZ (30 ml)

Lipotox

LIPOTOX 
squalene, cholesterinum, estradiol, progesterone, aspartame, benzalkonium chloride, formalinum, methylene chloride, methyl paraben, propyl paraben, sodium benzoate, sodium citrate, titanium dioxide, zincum oxydatum, arsenicum album, lycopodium clavatum, nux vomica, phosphoricum acidum, phosphorus, aceticum acidum, adrenocorticotrophin, benzoicum acidum, benzyl alcohol, boricum acidum, chlorinum, cortisone aceticum, eugenol, folliculinum, isopropyl palmitate, lacticum acidum, petroleum jelly liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0384
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SQUALENE (UNII: 7QWM220FJH) (SQUALENE - UNII:7QWM220FJH) SQUALENE8 [hp_X]  in 1 mL
CHOLESTEROL (UNII: 97C5T2UQ7J) (CHOLESTEROL - UNII:97C5T2UQ7J) CHOLESTEROL12 [hp_X]  in 1 mL
ESTRADIOL (UNII: 4TI98Z838E) (ESTRADIOL - UNII:4TI98Z838E) ESTRADIOL12 [hp_X]  in 1 mL
PROGESTERONE (UNII: 4G7DS2Q64Y) (PROGESTERONE - UNII:4G7DS2Q64Y) PROGESTERONE12 [hp_X]  in 1 mL
ASPARTAME (UNII: Z0H242BBR1) (ASPARTAME - UNII:Z0H242BBR1) ASPARTAME30 [hp_X]  in 1 mL
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE30 [hp_X]  in 1 mL
FORMALDEHYDE (UNII: 1HG84L3525) (FORMALDEHYDE - UNII:1HG84L3525) FORMALDEHYDE30 [hp_X]  in 1 mL
METHYLENE CHLORIDE (UNII: 588X2YUY0A) (METHYLENE CHLORIDE - UNII:588X2YUY0A) METHYLENE CHLORIDE30 [hp_X]  in 1 mL
METHYLPARABEN (UNII: A2I8C7HI9T) (METHYLPARABEN - UNII:A2I8C7HI9T) METHYLPARABEN30 [hp_X]  in 1 mL
PROPYLPARABEN (UNII: Z8IX2SC1OH) (PROPYLPARABEN - UNII:Z8IX2SC1OH) PROPYLPARABEN30 [hp_X]  in 1 mL
SODIUM BENZOATE (UNII: OJ245FE5EU) (BENZOIC ACID - UNII:8SKN0B0MIM) SODIUM BENZOATE30 [hp_X]  in 1 mL
ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL) ANHYDROUS TRISODIUM CITRATE30 [hp_X]  in 1 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE30 [hp_X]  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION30 [hp_X]  in 1 mL
ARSENIC TRIOXIDE (UNII: S7V92P67HO) (ARSENIC CATION (3+) - UNII:C96613F5AV) ARSENIC TRIOXIDE30 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479) LYCOPODIUM CLAVATUM SPORE30 [hp_X]  in 1 mL
STRYCHNOS NUX-VOMICA SEED (UNII: 269XH13919) (STRYCHNOS NUX-VOMICA SEED - UNII:269XH13919) STRYCHNOS NUX-VOMICA SEED30 [hp_X]  in 1 mL
PHOSPHORIC ACID (UNII: E4GA8884NN) (PHOSPHORIC ACID - UNII:E4GA8884NN) PHOSPHORIC ACID30 [hp_X]  in 1 mL
PHOSPHORUS (UNII: 27YLU75U4W) (PHOSPHORUS - UNII:27YLU75U4W) PHOSPHORUS30 [hp_X]  in 1 mL
ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID30 [hp_X]  in 1 mL
CORTICOTROPIN (UNII: K0U68Q2TXA) (CORTICOTROPIN - UNII:K0U68Q2TXA) CORTICOTROPIN30 [hp_X]  in 1 mL
BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM) BENZOIC ACID30 [hp_X]  in 1 mL
BENZYL ALCOHOL (UNII: LKG8494WBH) (BENZYL ALCOHOL - UNII:LKG8494WBH) BENZYL ALCOHOL30 [hp_X]  in 1 mL
BORIC ACID (UNII: R57ZHV85D4) (BORIC ACID - UNII:R57ZHV85D4) BORIC ACID30 [hp_X]  in 1 mL
CHLORINE (UNII: 4R7X1O2820) (CHLORINE - UNII:4R7X1O2820) CHLORINE30 [hp_X]  in 1 mL
CORTISONE ACETATE (UNII: 883WKN7W8X) (CORTISONE - UNII:V27W9254FZ) CORTISONE ACETATE30 [hp_X]  in 1 mL
EUGENOL (UNII: 3T8H1794QW) (EUGENOL - UNII:3T8H1794QW) EUGENOL30 [hp_X]  in 1 mL
ESTRONE (UNII: 2DI9HA706A) (ESTRONE - UNII:2DI9HA706A) ESTRONE30 [hp_X]  in 1 mL
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL30 [hp_X]  in 1 mL
LACTIC ACID, DL- (UNII: 3B8D35Y7S4) (LACTIC ACID, DL- - UNII:3B8D35Y7S4) LACTIC ACID, DL-30 [hp_X]  in 1 mL
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 [hp_X]  in 1 mL
PHENYLBUTAZONE (UNII: GN5P7K3T8S) (PHENYLBUTAZONE - UNII:GN5P7K3T8S) PHENYLBUTAZONE30 [hp_X]  in 1 mL
LEAD (UNII: 2P299V784P) (LEAD - UNII:2P299V784P) LEAD30 [hp_X]  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) (SORBIC ACID - UNII:X045WJ989B) POTASSIUM SORBATE30 [hp_X]  in 1 mL
RESORCINOL (UNII: YUL4LO94HK) (RESORCINOL - UNII:YUL4LO94HK) RESORCINOL30 [hp_X]  in 1 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID30 [hp_X]  in 1 mL
SORBITOL (UNII: 506T60A25R) (SORBITOL - UNII:506T60A25R) SORBITOL30 [hp_X]  in 1 mL
STEARYL ALCOHOL (UNII: 2KR89I4H1Y) (STEARYL ALCOHOL - UNII:2KR89I4H1Y) STEARYL ALCOHOL30 [hp_X]  in 1 mL
XYLITOL (UNII: VCQ006KQ1E) (XYLITOL - UNII:VCQ006KQ1E) XYLITOL30 [hp_X]  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
CASTOR OIL (UNII: D5340Y2I9G)  
BORAGE OIL (UNII: F8XAG1755S)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43857-0384-130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/11/201601/07/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic01/11/201601/07/2024
Labeler - BioActive Nutritional, Inc. (624980496)
Registrant - Apotheca Company (844330915)
Establishment
NameAddressID/FEIBusiness Operations
Apotheca Company844330915manufacture(43857-0384) , api manufacture(43857-0384) , label(43857-0384) , pack(43857-0384)

Revised: 9/2023
Document Id: e63abf17-f835-4af6-8397-a3f52399d5c2
Set id: 8300f65f-5c52-41ad-8f6a-6a951ab72fb7
Version: 3
Effective Time: 20230908
 
BioActive Nutritional, Inc.