NDC 43857-0384 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

NDC Product Code 43857-0384

NDC CODE: 43857-0384

Proprietary Name: Lipotox What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: 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 What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is a female hormone (estrogen). It is used by women to help reduce symptoms of menopause (such as hot flashes, vaginal dryness). These symptoms are caused by the body making less estrogen. If you are using this medication to treat symptoms only in and around the vagina, products applied directly inside the vagina should be considered before medications that are taken by mouth, absorbed through the skin, or injected. This medication may also be used by women who are not able to produce enough estrogen (for example, due to hypogonadism, primary ovarian failure). Certain estrogen products may also be used by women after menopause to prevent bone loss (osteoporosis). However, there are other medications (such as raloxifene, bisphosphonates including alendronate) that are also effective in preventing bone loss and may be safer. These medications should be considered for use before estrogen treatment.
  • Progesterone is a type of female hormone (progestin). This medication is similar to the progesterone that your body naturally makes. It is given to replace the hormone when your body is not making enough of it. In women who are not pregnant and have not gone through menopause, this medication is used to restore normal menstrual periods that have stopped for several months (amenorrhea). It is also used to treat abnormal bleeding from the uterus that is due to low hormone levels and not other causes (e.g., fibroids, cancer of the uterus). Progesterone must not be used to test for pregnancy. Progestins are not effective in preventing miscarriages.
  • This medication is used as an antiperspirant to treat feet that sweat or smell excessively. It is also used as a drying agent during wart treatment.
  • This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.
  • Arsenic trioxide is used to treat a type of leukemia (acute promyelocytic leukemia-APL).
  • Acetic acid is used to treat an outer ear infection (external otitis). It works by stopping the growth of bacteria and fungus. Treating the infection reduces pain and swelling in the ear. Wetness in the ear canal can help bacteria and fungus to grow. This medication may also contain drying ingredients such as glycerin or alcohol. Drying of the ear canal helps to cure the infection.
  • Drug uses not available
  • Cortisone is a corticosteroid hormone (glucocorticoid). It decreases your body's natural defensive response and reduces symptoms such as swelling and allergic-type reactions. This medication is used to treat conditions such as arthritis, blood/hormone/immune system disorders, allergic reactions, certain skin and eye conditions, breathing problems, and certain cancers.
  • Drug uses not available
  • This medication is used as a laxative to treat occasional episodes of constipation. Depending on the brand, this product may be taken by mouth and/or given rectally. Some products may only be given rectally. Be sure to check the label on your product for how to take your specific product.

NDC Code Structure

  • 43857 - Bioactive Nutritional, Inc.

NDC 43857-0384-1

Package Description: 30 mL in 1 BOTTLE, DROPPER

NDC Product Information

Lipotox with NDC 43857-0384 is a a human over the counter drug product labeled by Bioactive Nutritional, Inc.. The generic name of Lipotox is 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. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Bioactive Nutritional, Inc.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Lipotox Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SQUALENE 8 [hp_X]/mL
  • CHOLESTEROL 12 [hp_X]/mL
  • ESTRADIOL 12 [hp_X]/mL
  • PROGESTERONE 12 [hp_X]/mL
  • ASPARTAME 30 [hp_X]/mL
  • BENZALKONIUM CHLORIDE 30 [hp_X]/mL
  • FORMALDEHYDE 30 [hp_X]/mL
  • METHYLENE CHLORIDE 30 [hp_X]/mL
  • METHYLPARABEN 30 [hp_X]/mL
  • PROPYLPARABEN 30 [hp_X]/mL
  • SODIUM BENZOATE 30 [hp_X]/mL
  • ANHYDROUS TRISODIUM CITRATE 30 [hp_X]/mL
  • TITANIUM DIOXIDE 30 [hp_X]/mL
  • ZINC OXIDE 30 [hp_X]/mL
  • ARSENIC TRIOXIDE 30 [hp_X]/mL
  • LYCOPODIUM CLAVATUM SPORE 30 [hp_X]/mL
  • STRYCHNOS NUX-VOMICA SEED 30 [hp_X]/mL
  • PHOSPHORIC ACID 30 [hp_X]/mL
  • PHOSPHORUS 30 [hp_X]/mL
  • ACETIC ACID 30 [hp_X]/mL
  • CORTICOTROPIN 30 [hp_X]/mL
  • BENZOIC ACID 30 [hp_X]/mL
  • BENZYL ALCOHOL 30 [hp_X]/mL
  • BORIC ACID 30 [hp_X]/mL
  • CHLORINE 30 [hp_X]/mL
  • CORTISONE ACETATE 30 [hp_X]/mL
  • EUGENOL 30 [hp_X]/mL
  • ESTRONE 30 [hp_X]/mL
  • ISOPROPYL ALCOHOL 30 [hp_X]/mL
  • LACTIC ACID, DL- 30 [hp_X]/mL
  • PETROLATUM 30 [hp_X]/mL
  • PHENYLBUTAZONE 30 [hp_X]/mL
  • LEAD 30 [hp_X]/mL
  • POTASSIUM SORBATE 30 [hp_X]/mL
  • RESORCINOL 30 [hp_X]/mL
  • SALICYLIC ACID 30 [hp_X]/mL
  • SORBITOL 30 [hp_X]/mL
  • STEARYL ALCOHOL 30 [hp_X]/mL
  • XYLITOL 30 [hp_X]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • ALCOHOL (UNII: 3K9958V90M)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • BORAGE OIL (UNII: F8XAG1755S)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Bioactive Nutritional, Inc.
Labeler Code: 43857
Marketing Category: UNAPPROVED HOMEOPATHIC - What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 01-11-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Lipotox Product Label Images

Lipotox Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients:

Squalene 8X, Cholesterinum 12X, Estradiol 12X, Progesterone 12X, Aspartame 30X, Benzalkonium Chloride 30X, Formalinum 30X, Methylene Chloride 30X, Methyl Paraben 30X, Propyl Paraben 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.

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.

Inactive Ingredients:

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

Questions:

Distributed by:BIOACTIVE NUTRITIONALMelbourne, FL 32935For 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 HomeopathicLIPOTOX1 FL OZ (30 ml)

* Please review the disclaimer below.