Differin Acne Clearing Body Scrub
Salicylic Acid
Galderma Laboratories, L.p.
Human Otc Drug
NDC 0299-4609Differin Acne Clearing Body Scrub also known as Salicylic Acid is a human otc drug labeled by 'Galderma Laboratories, L.p.'. National Drug Code (NDC) number for Differin Acne Clearing Body Scrub is 0299-4609. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Differin Acne Clearing Body Scrub drug includes Salicylic Acid - 20 mg/mL . The currest status of Differin Acne Clearing Body Scrub drug is Active.
Drug Information:
| Drug NDC: | 0299-4609 |
| 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: | Differin Acne Clearing Body Scrub |
| 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: | Galderma Laboratories, L.p. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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 - 20 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: | 01 Jun, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 08 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: | Galderma Laboratories, L.P.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 562600
|
| 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: | 0302994609000
|
| 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 |
|---|
| 0299-4609-00 | 237 mL in 1 TUBE (0299-4609-00) | 01 Jun, 2021 | N/A | No |
| 0299-4609-05 | 15 mL in 1 TUBE (0299-4609-05) | 01 Jun, 2021 | 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:
Differin acne clearing body scrub salicylic acid salicylic acid salicylic acid butyl acrylate/methyl methacrylate/methacrylic acid copolymer (18000 mw) aloe vera leaf butylene glycol shea butter medium-chain triglycerides cocamidopropyl betaine coco-betaine coconut acid edetate disodium glycerin glycol distearate glycolic acid hypromellose, unspecified kaolin laureth-4 lauroyl/myristoyl methyl glucamide mannitol microcrystalline cellulose paraffin polyquaternium-39 (22.5/51/26.5 acrylic acid/acrylamide/dadmac; 1600000 mw) almond oil vitamin a palmitate silicon dioxide sodium c14-16 olefin sulfonate sodium chloride sodium hydroxide sodium sulfate cocoa butter .alpha.-tocopherol acetate ultramarine blue water 083276 p56865-0 differin acne body scrub 8oz tube
Indications and Usage:
Use for the management of acne
Warnings:
Warnings for external use only when using this product skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne treatment at a time. stop use and ask a doctor if irritation become severe 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 skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. if irritation occurs, only use one topical acne treatment at a time.
Dosage and Administration:
Directions apply to dampened skin and gently massage. rinse thoroughly with warm water. pat dry. if bothersome dryness or peeling occurs, reduce application use.
Stop Use:
Stop use and ask a doctor if irritation become severe
Package Label Principal Display Panel:
Principal display panel - 8 fl oz tube differin® cleanse acne-clearing body scrub 2% salicylic acid acne treatment when used daily, helps clear body breakouts contains glycolic acid to gently exfoliate and smooth vitamin e to nourish and soothe skin 8 fl oz (237 ml)