Acne Relief

Potassium Bromide, Syzygium Jambos Seed, Selenium

Boiron
Human Otc Drug
NDC 0220-9101

Acne Relief also known as Potassium Bromide, Syzygium Jambos Seed, Selenium is a human otc drug labeled by 'Boiron'. National Drug Code (NDC) number for Acne Relief is 0220-9101. This drug is available in dosage form of Pellet. The names of the active, medicinal ingredients in Acne Relief drug includes Potassium Bromide - 30 [hp_C]/1 Selenium - 6 [hp_C]/1 Syzygium Jambos Seed - 6 [hp_C]/1 . The currest status of Acne Relief drug is Active.

Drug Information:

Drug NDC:	0220-9101
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:	Acne 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:	Potassium Bromide, Syzygium Jambos Seed, Selenium
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name:	Boiron
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form:	Pellet
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:	POTASSIUM BROMIDE - 30 [hp_C]/1 SELENIUM - 6 [hp_C]/1 SYZYGIUM JAMBOS SEED - 6 [hp_C]/1
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:	ORAL
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:	16 May, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	23 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:	Boiron
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:	OSD78555ZM H6241UJ22B 97P0H45869
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
0220-9101-43	3 TUBE in 1 BOX (0220-9101-43) / 80 PELLET in 1 TUBE	16 May, 2022	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

Acne Relief

Potassium Bromide, Syzygium Jambos Seed, Selenium

Pellet
Boiron
NDC: 0220-9101

Purpose:

Purpose* eugenia jambosa 6c hpus (0.44 mg) ... treats blackheads associated with menstruation kali bromatum 30c hpus (0.44 mg) ... treats whitehead acne and scarring; sleeplessness with agitation selenium metallicum 6c hpus (0.44 mg) ... treats juvenile acne with blackheads and oily skin

Product Elements:

Acne relief potassium bromide, syzygium jambos seed, selenium potassium bromide bromide ion sucrose syzygium jambos seed syzygium jambos seed selenium selenium lactose, unspecified form

Indications and Usage:

Uses* temporarily relieves and treats occasional symptoms of acne (pimples) such as: blackheads oily skin whiteheads risk of scarring breakouts associated with puberty and menstrual periods

Warnings:

Dosage and Administration:

Directions keep packaging to save these directions for use. adults and children: acne with blackheads and oily skin: at the onset of symptoms, dissolve 5 pellets each of selenium 6c and eugenia jambosa 6c under the tongue 3 times a day until symptoms are relieved or as directed by a doctor. acne with whiteheads and blackheads: at the onset of symptoms, dissolve 5 pellets each of kali bromatum 30c and selenium 6c under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

Stop Use:

Stop and ask a doctor if symptoms persist for more than 3 days or worsen skin irritation occurs, gets worse, or is severe.

Package Label Principal Display Panel:

Label

Further Questions:

Boironusa.com info@boiron.com 1-800-boiron-1 (1-800-264-7661) made in france distributed by boiron, inc. newtown square, pa 19073

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.