Blemfree
Salicylic Acide
Equibal, Inc.
Human Otc Drug
NDC 53228-003Blemfree also known as Salicylic Acide is a human otc drug labeled by 'Equibal, Inc.'. National Drug Code (NDC) number for Blemfree is 53228-003. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Blemfree drug includes Salicylic Acid - 1500 mg/29000mg . The currest status of Blemfree drug is Active.
Drug Information:
| Drug NDC: | 53228-003 |
| 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: | Blemfree |
| 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 Acide |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Equibal, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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 - 1500 mg/29000mg
|
| 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 Aug, 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. |
| Application Number: | part333D |
| 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: | Equibal, 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: | 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 NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 53228-003-01 | 29000 mg in 1 TUBE (53228-003-01) | 01 Aug, 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. |
Purpose:
Purpose management of acne
Product Elements:
Blemfree salicylic acide salicylic acid salicylic acid mentha spicata oil
Indications and Usage:
Indications and usage management of acne
Warnings:
Warnings for external use only. do not use more than one acne product at a time.
When Using:
When using when using product do not get into eyes. if contact occurs, rinse eyes thoroughly with water.
Dosage and Administration:
Dosage & administration after area is wet with blemfree⢠cleansing wash concentrate has foamed, tap blemfree⢠cleansing spheres with fingertips and massage in small circles for 60 seconds. proceed to rinse step.
Stop Use:
Stop use stop use and ask a doctor if irritation and redness become severe.
Package Label Principal Display Panel:
Package label made in usa â not tested on animals patent# 8,603,550 equibal labs, inc. 1(800)247-2405 63-65 jersey ave, blemfree.com unionville, ny 10988 blemfree ⢠a natural approach to fight acne all-day lotion this patented antibacterial lotion protects your skin all day while fighting bacteria. the astringent formula breaks down excess oils without causing redness or excessive dryness. 1 oz. 29 ml retain insert for full product uses, directions, warnings, and drug facts. directions: after using blemfree⢠cleansing wash concentrate and toner & balancer in the morning, smooth a thin layer of blemfree⢠all-day lotion on your face, neck, or back. start with one application daily, then increase to two times daily if needed or as directed by a doctor. blemfree all day lotion
Blemfree all day lotion package insert cleansing wash concentrate ingredients: sodium laureth sulfate, sodium methocoyl taurate, ro water (aqua), cocamidopropyl betaine, 2- (dodecanoyl methyl) amino) acetic acid, hexylene glycol, phenocyethanol, capryl diol, methylcellulose, witch hazel (hamamelis virginiana) extract, chamomilla (matricaria recutita) extract, rosmarius officnalis (rosemary) leaf oil, mentha spicata (spearmint) oil. directions : dampen face by cupping lukewarm water in both hands. add some blemfree⢠cleansing wash to one palm and coat fingers. massage in a circular motion till foam appears. tap the blemfree⢠cleansing spheres with wet fingertips and massage 60 seconds in small circles working toward the center of the face. add water and continue massaging until the foam starts to subside. rinse 4 times with lukewarm water and then 4 times with cool water. pat dry. apply blemfree⢠toner & balancer to area with a cotton pad. then apply blemfree⢠all-day lotion in a thin film all over. toner & balancer ingredients: ro water(aqua), witch hazel (hamamelis virginiana) water, peg 8, chlorhexidine digluconate, chamomilla (matricaria recutita) extract, witch hazel (hamamelis virginiana) extract, mentha spicata (spearmint) leaf oil, rosmarinus officinalis (rosemary leaf oil, polysorbate 20. directions: wash face with blemfree⢠cleansing wash concentrate, pat dry. use a cotton ball or pad to apply tone & balancer on your face, neck and/or back. made in usa â not tested on animals cleansing spheres ingredients: jojoba spheres directions: after area is wet with blemfree⢠cleansing wash concentrate has foamed, tap blemfree⢠cleansing spheres with fingertips and massage in small circles for 60 seconds. proceed to rinse step. all-day lotion drug facts use(s): management of acne active ingredient purpose salicylic acid 0.5% w/w management of acne warnings: for external use only. do not use more than one acne product at a time. ask doctor if pregnant or breastfeeding. when using product do not get into eyes. if contact occurs, rinse eyes thoroughly with water. stop use and ask a doctor if irritation and redness become severe. do not use in conjunction with other products containing acids or benzoyl peroxide. do not use harsh cleaning pads or brushes. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. inactive ingredients: behentrimonium methosulfate, benzethonium chloride, bisabolol, butylene glycol, cetyl alcohol, chamomilla (matricaria recutita) extract, chlorhexidine gluconate, dimethicone, mentha spicata (spearmint) oil, menthyl lactate, octydodecanol, phenoxyethhanol, polyguatemium-37, rosemary (rosmarinus officinalis) leaf oil, stearic acid, water (aqua), witch hazel (hamamelis virginiana) extract. directions: after using blemfree⢠cleansing wash concentrate and toner & balancer in the morning, smooth a thin layer of blemfree⢠all-day lotion on your face, neck or back. start with one application daily, then increase to two times daily if needed or as directed by a doctor. blemfree all day lotion insert