Acne Relief Cream
Salicylic Acid 0.5%
Hempfusion, Inc.
Human Otc Drug
NDC 73672-981Acne Relief Cream also known as Salicylic Acid 0.5% is a human otc drug labeled by 'Hempfusion, Inc.'. National Drug Code (NDC) number for Acne Relief Cream is 73672-981. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Acne Relief Cream drug includes Salicylic Acid - 5 mg/mL . The currest status of Acne Relief Cream drug is Active.
Drug Information:
| Drug NDC: | 73672-981 |
| 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 Cream |
| 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 0.5% |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Hempfusion, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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 - 5 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: | 10 Feb, 2020 |
| 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: | HEMPFUSION, 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 |
|---|
| 73672-981-30 | 1 TUBE in 1 CARTON (73672-981-30) / 30 mL in 1 TUBE | 10 Feb, 2020 | 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 salicylic acid 0.5%..acne treatment
Product Elements:
Acne relief cream salicylic acid 0.5% black pepper oil clove oil cetearyl glucoside pullulan isostearic acid linalool, (+/-)- limonene, (+)- silicon dioxide glucose oxidase lavender oil glycerin cetearyl olivate rosa canina fruit oil cetostearyl alcohol anhydrous dextrose cupressus sempervirens leaf oil peppermint oil peppermint cannabis sativa seed oil sorbitan olivate oatmeal aloe lysophosphatidylcholine, soybean myeloperoxidase coco-caprylate dimethyl sulfone citric acid monohydrate hemp zinc oxide medium-chain triglycerides water polyhydroxystearic acid (2300 mw) xanthan gum betasizofiran willow bark salicylic acid salicylic acid
Indications and Usage:
Uses for the treatment of acne.
Warnings:
Warnings for external use only when using this product 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 a doctor. avoid contact with eyes. if contact occurs, flush thoroughly with water. keep out of reach of children. if swallowed, get medical help or contact a poison control center right away.
When Using:
When using this product 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 a doctor. avoid contact with eyes. if contact occurs, flush thoroughly with water.
Dosage and Administration:
Directions cleanse the skin thoroughly before applying the medication cover the entire affected area with a thin layer one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor if bothersome dryness of peeling occurs, reduce application to once a day or every other day
Package Label Principal Display Panel:
Hemp fusion acne relief cream salicylic acid 0.5% including nourishing willow bark , hemp extract with naturally occuring cbd (60mg/bottle) + terpenes (35mg/bottle) from black pepper and clove & other natural skin moisturizers us hemp authority h certified non-gmo all skin types 30ml (1.01 fl oz) box label
Further Questions:
Manufactured for hemp fusion(r) 3820 nw 14th street suite a & b topeka, ks 66618 877.now.hemp (877.669.4367) hempfusion.com