Al00933 Alba Botanica Fast Fix Papaya Anti Acne Sheet Mask
Salicylic Acid
The Hain Celestial Group, Inc.
Human Otc Drug
NDC 61995-2933Al00933 Alba Botanica Fast Fix Papaya Anti Acne Sheet Mask also known as Salicylic Acid is a human otc drug labeled by 'The Hain Celestial Group, Inc.'. National Drug Code (NDC) number for Al00933 Alba Botanica Fast Fix Papaya Anti Acne Sheet Mask is 61995-2933. This drug is available in dosage form of Cloth. The names of the active, medicinal ingredients in Al00933 Alba Botanica Fast Fix Papaya Anti Acne Sheet Mask drug includes Salicylic Acid - 2 g/1 . The currest status of Al00933 Alba Botanica Fast Fix Papaya Anti Acne Sheet Mask drug is Active.
Drug Information:
| Drug NDC: | 61995-2933 |
| 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: | Al00933 Alba Botanica Fast Fix Papaya Anti Acne Sheet Mask |
| 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: | The Hain Celestial Group, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cloth |
| 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/1
|
| 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: | 16 Aug, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 Jun, 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: | The Hain Celestial Group, Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 797885
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0724742009335
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 61995-2933-1 | 1 CLOTH in 1 PACKET (61995-2933-1) | 16 Aug, 2016 | 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:
Acne treatment
Product Elements:
Al00933 alba botanica fast fix papaya anti acne sheet mask salicylic acid salicylic acid salicylic acid aloe vera leaf water glycerin papaya coconut water melissa officinalis leaf betaine biosaccharide gum-1 carrageenan citric acid monohydrate .gamma.-undecalactone sodium levulinate coconut juice alcohol allantoin geranyl acetate hexyl acetate hydrolyzed jojoba esters (acid form) potassium hydroxide sodium anisate sucrose laurate triethyl citrate vanillin medium-chain triglycerides orange oil green tea leaf alpha-tocopherol acetate phenoxyethanol carrot dextrose potassium sorbate sodium benzoate lemon oil glyceryl monocaprylate
Indications and Usage:
For the treatment of acne.
Warnings:
For external use only. using other topical acne medications at the same time or immediately following the use of this product may increase dryiness or irritation of skin. if this occurs, only one drug should be used unless directed by a doctor. avoid direct contact wit eyes. if the contact occurs, flush throughly with water.
Dosage and Administration:
1. clean and dry face. 2. carefully unfold mask and apply to face, adjusting around eyes, nose and mouth and smoothing over curves. 3. leave on for 5-15 minutes. 4. remove and discard. 5.gentle massage remaining serum into skin. no rinsing required.
Package Label Principal Display Panel:
Mask label
Further Questions:
Questions? call (888)-659-7730 or visit www.albabotanica.com