Resurfacing Acne Swipes
Salicylic Acid
Oars And Alps Llc
Human Otc Drug
NDC 83046-100Resurfacing Acne Swipes also known as Salicylic Acid is a human otc drug labeled by 'Oars And Alps Llc'. National Drug Code (NDC) number for Resurfacing Acne Swipes is 83046-100. This drug is available in dosage form of Swab. The names of the active, medicinal ingredients in Resurfacing Acne Swipes drug includes Salicylic Acid - .005 mg/mL . The currest status of Resurfacing Acne Swipes drug is Active.
Drug Information:
| Drug NDC: | 83046-100 |
| 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: | Resurfacing Acne Swipes |
| 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: | Oars And Alps Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Swab |
| 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 - .005 mg/mL
|
| 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: | 22 Dec, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 04 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: | Oars And Alps LLC
|
| 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 |
|---|
| 83046-100-30 | 1 JAR in 1 BOX (83046-100-30) / 1 mL in 1 JAR | 22 Dec, 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. |
Purpose:
Purpose acne treatment
Product Elements:
Resurfacing acne swipes salicylic acid levomenol diglycerin salicylic acid salicylic acid glycolic acid salix alba bark tetrasodium glutamate diacetate water hamamelis virginiana top cladonia rangiferina whole sodium hydroxide propanediol polysorbate 20 tea tree oil phenoxyethanol ethylhexylglycerin aloe vera leaf round pads white round pads impregnated with topical acne solution
Indications and Usage:
Uses for the treatment of acne reduces the number of acne pimples and blackheads allows skin to heal helps prevent new acne pimples from forming
Warnings:
Warnings for external use only do not use if you have very sensitive skin or known allergy to aspirin stop use ask a doctor if excessive itching, dryness, redness, burning or swelling occurs, or if these symptoms persist when using this product ⢠keep away from eyes, lips and other mucous membranes. if contact occurs, flush thoroughly with water. ⢠do not leave pad on the skin for an extended period of time. ⢠using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. if this occurs, only one medication should be used unless directed by doctor
Warnings and Cautions:
Other information sunburn alert: this product contains an alpha hydroxy acid (aha) that may increase your skinâs sensitivity to the sun and particularly the possibility of sunburn. use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.
Dosage and Administration:
Directions cleanse the skin thoroughly before using the product use the pad to clean and treat the entire affected area one to three times daily do not rinse because excessive drying of the skin may occur, start with one application daily, then gradually increase if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce the application keep jar tightly closed store at room temperature
Package Label Principal Display Panel:
Label oars+alps anti- everything pad with 10% glycolic acid anti-agne +anti-aging + anti-pollution + anti-ingrown hairs 28 biodegradable pads directions: gently wipe over clean face and neck, avoiding the eye area. do not rinse. once absorbed, follow with a gentle moisturizer. can be used daily. if bothersome dryness or peeling occurs, reduce the application. this formula contains an alpha hydroxy acid (aha) which can increase skinâs sensitivity to the sun. be sure to apply spf daily when using this product. caution: for external use only. avoid eye area. if product gets in your eyes, rinse thoroughly. manufactured for oars + alps llc, chicago, il 60661 made in usa 3m 5 pp oars+alps anti- everything pad with 10% glycolic acid anti-agne + anti-aging + anti-pollution + anti-ingrown hairs 28 biodegradable pads cruelty free + gluten free + vegan free of alcohol, fragrance parabens, phthalates, sulfates our pads help clear your complexion and minimize the appearance of pores. this plant based formula contains glycolic acid and salicylic acid for a gentle chemical exfoliation that help refresh your surface skin cell layer and energize your skin. oarsandalps.com #taketotheoars do not flush manufactured for oars + alps llc chicago, il 60661 made in usa 3m 8 50000 02633 9 label label label
Further Questions:
Questions or comments email us at hi@oarsandalps.com, or call (630) 635-7839