Cold Sore Rescue

Borax, Dulcamara, Natrum Muriaticum, Ranunculus Bulbosus, Silicea

Peaceful Mountain, Inc.
Human Otc Drug
NDC 43846-0031

Cold Sore Rescue also known as Borax, Dulcamara, Natrum Muriaticum, Ranunculus Bulbosus, Silicea is a human otc drug labeled by 'Peaceful Mountain, Inc.'. National Drug Code (NDC) number for Cold Sore Rescue is 43846-0031. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Cold Sore Rescue drug includes Ranunculus Bulbosus Whole - 30 [hp_X]/g Silicon Dioxide - 30 [hp_X]/g Sodium Borate - 30 [hp_X]/g Sodium Chloride - 30 [hp_X]/g Solanum Dulcamara Top - 30 [hp_X]/g . The currest status of Cold Sore Rescue drug is Active.

Drug Information:

Drug NDC:	43846-0031
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:	Cold Sore Rescue
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:	Borax, Dulcamara, Natrum Muriaticum, Ranunculus Bulbosus, Silicea
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Peaceful Mountain, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Gel
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:	RANUNCULUS BULBOSUS WHOLE - 30 [hp_X]/g SILICON DIOXIDE - 30 [hp_X]/g SODIUM BORATE - 30 [hp_X]/g SODIUM CHLORIDE - 30 [hp_X]/g SOLANUM DULCAMARA TOP - 30 [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:	08 Dec, 2014
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	07 May, 2026
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:	Peaceful Mountain, Inc.
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.
UNII:	AEQ8NXJ0MB ETJ7Z6XBU4 91MBZ8H3QO 451W47IQ8X KPS1B1162N
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.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
43846-0031-2	1 TUBE in 1 CARTON (43846-0031-2) / 7 g in 1 TUBE (43846-0031-1)	08 Dec, 2014	N/A	No
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.

Other medicines with the same generic name

Cold Sore Rescue

Borax, Dulcamara, Natrum Muriaticum, Ranunculus Bulbosus, Silicea

Gel
Peaceful Mountain, Inc.
NDC: 43846-0031

Purpose:

Uses: may temporary relief symptoms of cold sores and fever blisters such as: stinging - itching - swelling of minor herpatic skin eruptions of the face or genitals.** **claims based on traditional homeopathic practice, not accepted medical evidence. not fda evaluated.

Product Elements:

Cold sore rescue borax, dulcamara, natrum muriaticum, ranunculus bulbosus, silicea sodium borate borate ion solanum dulcamara top solanum dulcamara top sodium chloride chloride ion ranunculus bulbosus whole ranunculus bulbosus whole silicon dioxide silicon dioxide aloe vera leaf arnica montana flower carbomer homopolymer type c larrea tridentata leaf comfrey leaf edetate disodium lavandula angustifolia flower melissa officinalis leaf oregano polyethylene glycol 1600 peg-8 dimethicone polyethylene glycol 700 phenoxyethanol caprylyl glycol sorbic acid phytolacca americana fruit phytolacca americana root potassium sorbate water sodium hydroxide st. john's wort ascorbic acid .alpha.-tocopherol salix alba bark achillea millefolium flower citric acid monohydrate alcohol sodium benzoate

Indications and Usage:

Warnings:

Warnings: for external use only. when using this product - do not get into eyes. stop use and ask a doctor if: condition worsens - symptoms last more than 7 days keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. if pregnant or breast-feeding, ask a health professional before use. do not use if tamper evident seal is broken or missing.

Dosage and Administration:

Directions: apply at least 3 times daily over affected area. children under 12 years of age: consult a doctor.

Package Label Principal Display Panel:

Package label display: homeopathic relief may temporarily relieve cold sore and fever blisters symptoms may help temporarily relieve stinging, burning, itching and swelling peaceful mountain the height of health formulated in boulder, co cold sore rescue homeopathic gel net wt. 0.25 oz. (7 g) cold sore rescue tube cold sore rescue carton

Further Questions:

Questions: 888-303-3388 mon-fri 8 a.m.-5 p.m. ct dist. by peaceful mountain, inc., woodbine, ia 51579 www.peacefulmountain.com

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.