Pinkeye Relief

Aconitum Napellus Root, Apis Mellifera, Silver Nitrate, Euphrasia Stricta, Sodium Arsenate Dibasic Heptahydrate, Valerian


Trp Company
Human Otc Drug
NDC 17312-166
Pinkeye Relief also known as Aconitum Napellus Root, Apis Mellifera, Silver Nitrate, Euphrasia Stricta, Sodium Arsenate Dibasic Heptahydrate, Valerian is a human otc drug labeled by 'Trp Company'. National Drug Code (NDC) number for Pinkeye Relief is 17312-166. This drug is available in dosage form of Ointment. The names of the active, medicinal ingredients in Pinkeye Relief drug includes Aconitum Napellus Root - 6 [hp_X]/g Apis Mellifera - 6 [hp_X]/g Euphrasia Stricta - 6 [hp_X]/g Silver Nitrate - 12 [hp_X]/g Sodium Arsenate, Dibasic Heptahydrate - 11 [hp_X]/g Valerian - 6 [hp_X]/g . The currest status of Pinkeye Relief drug is Active.

Drug Information:

Drug NDC: 17312-166
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.
Proprietary Name: Pinkeye Relief
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Otc Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Aconitum Napellus Root, Apis Mellifera, Silver Nitrate, Euphrasia Stricta, Sodium Arsenate Dibasic Heptahydrate, Valerian
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Trp Company
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Ointment
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:ACONITUM NAPELLUS ROOT - 6 [hp_X]/g
APIS MELLIFERA - 6 [hp_X]/g
EUPHRASIA STRICTA - 6 [hp_X]/g
SILVER NITRATE - 12 [hp_X]/g
SODIUM ARSENATE, DIBASIC HEPTAHYDRATE - 11 [hp_X]/g
VALERIAN - 6 [hp_X]/g
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:TOPICAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: UNAPPROVED HOMEOPATHIC
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 28 May, 2018
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 22 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:TRP Company
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
Original Packager:Yes
Whether or not the drug has been repackaged for distribution.
UPC:0858961001662
UPC stands for Universal Product Code.
NUI:N0000185021
N0000175629
N0000184306
N0000185001
M0000728
M0002274
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:KPD2N7348X
7S82P3R43Z
C9642I91WL
95IT3W8JZE
90ZQ7G407W
JWF5YAW3QW
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.
Pharmacologic Class EPC:Standardized Insect Venom Allergenic Extract [EPC]
Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`.
Pharmacologic Class PE:Increased Histamine Release [PE]
Cell-mediated Immunity [PE]
Increased IgG Production [PE]
Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`.
Pharmacologic Class CS:Allergens [CS]
Bee Venoms [CS]
Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient].
Pharmacologic Class:Allergens [CS]
Bee Venoms [CS]
Cell-mediated Immunity [PE]
Increased Histamine Release [PE]
Increased IgG Production [PE]
Standardized Insect Venom Allergenic Extract [EPC]
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
17312-166-131 TUBE in 1 PACKAGE (17312-166-13) / 4 g in 1 TUBE28 May, 2018N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Purpose:

Aconite hpus........................swelling, redness apis hpus.............................swelling argentum nitriucm hpus.......burning euphrasia hpus....................watering natrum arsenicicum hpus....grittiness, overnight crusting valeriana officinallis hpus.....sleeplessness

Product Elements:

Pinkeye relief aconitum napellus root, apis mellifera, silver nitrate, euphrasia stricta, sodium arsenate dibasic heptahydrate, valerian apis mellifera apis mellifera euphrasia stricta euphrasia stricta sodium arsenate, dibasic heptahydrate arsenate ion valerian valerian silver nitrate silver cation petrolatum lactose lanolin alcohols mineral oil aconitum napellus root aconitum napellus root

Indications and Usage:

Indications and uses uses* according to homeopathic indications these ingredients provide temporary relief from symptoms such as: • redness • burning sensations •watering •swelling •sensation of grittiness • sleeplessness and overnight crusting; after serious causes have been ruled out by a physician. *these statements are based upon traditional homeopathic practice. they have not been reviewed by the food and drug administration.

Warnings:

Warnings: a physician should always be consulted to rule out serious causes. for external use only. this product is intended to complement, not replace, standard medical treatment. initial worsening of symptoms may occur.

Replace cap after every use. to avoid contamination: do not touch tip to any surface. use within 30 days of opening. expiration date only refers to the unopened tube. the use of this container by more than one person may spread infection. contact lens wearers: consult a physician before use.

Do Not Use:

Warnings: a physician should always be consulted to rule out serious causes. for external use only. this product is intended to complement, not replace, standard medical treatment. initial worsening of symptoms may occur.

Replace cap after every use. to avoid contamination: do not touch tip to any surface. use within 30 days of opening. expiration date only refers to the unopened tube. the use of this container by more than one person may spread infection. contact lens wearers: consult a physician before use.

Dosage and Administration:

Directions: suitable for adults and children ages 2 and over. children under the age of 2: consult a physician before use. wash your hands. squeeze out approx. 1/8” of ointment onto fingertip. gently apply directly to affected area. apply before bedtime. homeopathic remedies may not be effective for everyone. individual results may vary.

Stop Use:

Stop use and ask a doctor if: you experience eye pain, changes in vision, continued redness or irritation of the eye. the condition worsens. the condition last longer than 72 hours.

Package Label Principal Display Panel:

Do not use if tamper evident carton seals are torn, broken or missing. fda disclaimer: claims based on traditional homeopathic practice, not medical evidence. not fda evaluated. carton label

Further Questions:

Questions? call: 888-969-6855


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.