Pur 4-in-1 Correcting Primer

Salicylic Acid


Purminerals
Human Otc Drug
NDC 67345-0380
Pur 4-in-1 Correcting Primer also known as Salicylic Acid is a human otc drug labeled by 'Purminerals'. National Drug Code (NDC) number for Pur 4-in-1 Correcting Primer is 67345-0380. This drug is available in dosage form of Emulsion. The names of the active, medicinal ingredients in Pur 4-in-1 Correcting Primer drug includes Salicylic Acid - 2 g/100mL . The currest status of Pur 4-in-1 Correcting Primer drug is Active.

Drug Information:

Drug NDC: 67345-0380
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: Pur 4-in-1 Correcting Primer
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: Salicylic Acid
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Purminerals
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Emulsion
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:SALICYLIC ACID - 2 g/100mL
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: OTC MONOGRAPH FINAL
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: 01 Jan, 2020
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 15 Jan, 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.
Application Number: M006
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
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:Purminerals
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:O414PZ4LPZ
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 NDCDescriptionMarketing Start DateMarketing End DateSample Available
67345-0380-21 TUBE in 1 CARTON (67345-0380-2) / 30 mL in 1 TUBE (67345-0380-1)01 Jan, 2020N/ANo
67345-0380-310 mL in 1 TUBE (67345-0380-3)01 Jan, 2020N/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:

Acne medication

Product Elements:

Pur 4-in-1 correcting primer salicylic acid alteromonas macleodii buddleja officinalis flower butylene glycol shea butter camellia sinensis flower caprylyl glycol ceramide ap activated charcoal citric acid monohydrate decyl glucoside dimethicone glycerin hexylene glycol hydroxyethyl cellulose, unspecified lactic acid, l- niacinamide panax ginseng root water pentylene glycol phenoxyethanol polyisobutylene (1000 mw) polymethylsilsesquioxane (11 microns) dimethicone/vinyl dimethicone crosspolymer (soft particle) polysorbate 20 potassium sorbate propanediol retinol sodium hydroxide sodium starch glycolate type a water salicylic acid salicylic acid

Indications and Usage:

Uses for the treatment of acne

Warnings:

Warnings for external use only keep out of reach of children. if swallowed, call a poison control center or get medical help right away skin irritation and dryness are more likely to occur when using another topical acne product at the same time. if irritation occurs, rinse thoroughly with water avoid contact with eyes. if contact occurs, rinse thoroughly with water. for more severe cases, or if improvement is not apparent within 6-8 weeks, consult a health care professional. ?know adverse reaction(s): ? if you develop severe irritation, burning or itching of the skin, discontinue use and consult a health care professional. if you develop hives, swelling of the eyes and mouth, blistering or difficulty breathing, get medical help right away. when using this product skin irritation and dryness are more likely to occur when using another topical acne product at the same time. if irritation occurs, rinse thoroughly with water avoid contact with eyes. if contact occurs, rinse thoroughly wit
h water. keep out of reach of children. keep out of reach of children. if swallowed, call a poison control center or get medical help right away

When Using:

When using this product skin irritation and dryness are more likely to occur when using another topical acne product at the same time. if irritation occurs, rinse thoroughly with water avoid contact with eyes. if contact occurs, rinse thoroughly with water. keep out of reach of children. keep out of reach of children. if swallowed, call a poison control center or get medical help right away

Dosage and Administration:

Directions clean the skin thoroughly before applying the product ?for new users apply product to a small area once a day for three days to test if you are sensitive to this product, if not discomfort occurs, cover the entire affected area with a thin layer start with one application daily, the gradually increase to two or three times daily if needed. if dryness or peeling occurs, reduce application to once a day or every other day. keep carton fo additional directions and warning information

Package Label Principal Display Panel:

Acneprimer


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.