71753-9012 NDC - KLEAN DETOX (AESCULUS HIPPOCASTANUM, EQUISETUM HYEMALE, HYDRASTIS CANADENSIS, HYDROCOTYLE ASIATICA, LINUM USITATISSIMUM, MAGNESIA MURIATICA, PASSIFLORA INCARNATA, SOLIDAGO VIRGAUREA, THUJA OCCIDENTALIS, FUMARIA OFFICINALIS, ONONIS SPINOSA)

Drug Information

Product NDC: 71753-9012
Proprietary Name: Klean Detox
Non Proprietary Name: Aesculus Hippocastanum, Equisetum Hyemale, Hydrastis Canadensis, Hydrocotyle Asiatica, Linum Usitatissimum, Magnesia Muriatica, Passiflora Incarnata, Solidago Virgaurea, Thuja Occidentalis, Fumaria Officinalis, Ononis Spinosa
Active Ingredient(s): 6 [hp_X]/mL CENTELLA ASIATICA WHOLE; 6 [hp_X]/mL EQUISETUM HYEMALE WHOLE; 6 [hp_X]/mL FLAX SEED; 8 [hp_X]/mL FUMARIA OFFICINALIS FLOWERING TOP; 6 [hp_X]/mL GOLDENSEAL; 6 [hp_X]/mL HORSE CHESTNUT; 6 [hp_X]/mL MAGNESIUM CHLORIDE; 6 [hp_C]/mL ONONIS SPINOSA WHOLE; 6 [hp_X]/mL PASSIFLORA INCARNATA FLOWERING TOP; 6 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP; 6 [hp_X]/mL THUJA OCCIDENTALIS LEAFY TWIG
Administration Route(s): ORAL
Dosage Form(s): SPRAY
Pharmacy Class(es): Allergens [CS]; Calculi Dissolution Agent [EPC]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]; Magnesium Ion Exchange Activity [MoA]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Plant Allergenic Extract [EPC]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Plant Proteins [CS]; Seed Storage Proteins [CS]; Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

Labeler Information

Field Name	Field Value
Labeler Name:	Ratis, LLC
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	11/8/2024

Package Information

No.	Package Code	Package Description	Billing Unit
1	71753-9012-1	30 mL in 1 BOTTLE, SPRAY (71753-9012-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	71753-9012	The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAME	HUMAN OTC DRUG	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.
PROPRIETARY NAME	Klean Detox	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	Aesculus Hippocastanum, Equisetum Hyemale, Hydrastis Canadensis, Hydrocotyle Asiatica, Linum Usitatissimum, Magnesia Muriatica, Passiflora Incarnata, Solidago Virgaurea, Thuja Occidentalis, Fumaria Officinalis, Ononis Spinosa	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	SPRAY	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	ORAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	11/8/2024	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	UNAPPROVED HOMEOPATHIC	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.
LABELER NAME	Ratis, LLC	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	CENTELLA ASIATICA WHOLE; EQUISETUM HYEMALE WHOLE; FLAX SEED; FUMARIA OFFICINALIS FLOWERING TOP; GOLDENSEAL; HORSE CHESTNUT; MAGNESIUM CHLORIDE; ONONIS SPINOSA WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG	An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH	6; 6; 6; 8; 6; 6; 6; 6; 6; 6; 6
ACTIVE INGRED UNIT	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
PHARM CLASSES	Allergens [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

71753-9012 NDC - KLEAN DETOX (AESCULUS HIPPOCASTANUM, EQUISETUM HYEMALE, HYDRASTIS CANADENSIS, HYDROCOTYLE ASIATICA, LINUM USITATISSIMUM, MAGNESIA MURIATICA, PASSIFLORA INCARNATA, SOLIDAGO VIRGAUREA, THUJA OCCIDENTALIS, FUMARIA OFFICINALIS, ONONIS SPINOSA)

Drug Information

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