Label: LIPOTOX- 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

  • NDC Code(s): 43857-0636-1
  • Packager: BioActive Nutritional, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

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 Label Information

Updated September 5, 2023

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  • 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, 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:

    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:

    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, Inc.

    1803 N. Wickham Rd.

    Melbourne, FL 32935

    bioactivenutritional.com

  • PACKAGE LABEL DISPLAY:

    BIOActiveNutritional

    LIPOTOX

    HOMEOPATHIC

    1 FL OZ (30 ml)

    LIPOTOX

  • INGREDIENTS AND APPEARANCE
    LIPOTOX 
    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
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43857-0636
    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 SOLUTION (UNII: T0H3L6C7I5) (FORMALDEHYDE SOLUTION - UNII:T0H3L6C7I5) FORMALDEHYDE SOLUTION30 [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
    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 PALMITATE (UNII: 8CRQ2TH63M) (ISOPROPYL PALMITATE - UNII:8CRQ2TH63M) ISOPROPYL PALMITATE30 [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
    CORTICOTROPIN (UNII: K0U68Q2TXA) (CORTICOTROPIN - UNII:K0U68Q2TXA) CORTICOTROPIN30 [hp_C]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BORAGE OIL (UNII: F8XAG1755S)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43857-0636-130 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product09/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/05/2023
    Labeler - BioActive Nutritional, Inc. (624980496)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43857-0636) , api manufacture(43857-0636) , label(43857-0636) , pack(43857-0636)
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