Riversol Comprehensive Acne Treatment
Salicylic Acid
Riversol Skincare Solutions Inc
Human Otc Drug
NDC 72019-0002Riversol Comprehensive Acne Treatment also known as Salicylic Acid is a human otc drug labeled by 'Riversol Skincare Solutions Inc'. National Drug Code (NDC) number for Riversol Comprehensive Acne Treatment is 72019-0002. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Riversol Comprehensive Acne Treatment drug includes Salicylic Acid - .18 g/30g . The currest status of Riversol Comprehensive Acne Treatment drug is Active.
Drug Information:
| Drug NDC: | 72019-0002 |
| 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: | Riversol Comprehensive Acne Treatment |
| 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: | Riversol Skincare Solutions 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 - .18 g/30g
|
| 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 Mar, 2020 |
| 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: | part358B |
| 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: | Riversol Skincare Solutions Inc
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 199135
|
| 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. |
| 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 |
|---|
| 72019-0002-1 | 1 BOTTLE, PUMP in 1 BOX (72019-0002-1) / 30 g in 1 BOTTLE, PUMP | 01 Mar, 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:
For the management of acne
Product Elements:
Riversol comprehensive acne treatment salicylic acid citric acid monohydrate medium-chain triglycerides water polysorbate 60 salicylic acid salicylic acid octyldodecanol 1,9-decadiene xanthan gum propylene glycol phenoxyethanol sodium hydroxide sodium nitrite nitrite ion glyceryl monostearate cetostearyl alcohol peg-100 stearate
Indications and Usage:
Directions for new users: apply to a small area once daily for 3 days to test for sensitivity. if no discomfort occurs, dispense 2 pumps from each side. ⢠thoroughly blend the product and cover the affected area 1-3 times daily. ⢠if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Warnings:
Warnings external use only. ⢠irritation and dryness are more likely if you use another topical acne product at the same time. ⢠if irritation occurs, use only one product. ⢠avoid contact with eyes. if contact occurs, flush thoroughly with water. ⢠keep out of reach of children. ⢠if swallowed, or if you develop hives, swelling of eyes and mouth, blistering, or difficulty breathing get medical help or contact a poison control center right away.
When Using:
Directions: clean the skin thoroughly ⢠for new users: apply to a small area once daily for 3 days to test for sensitivity. if no discomfort occurs, dispense 2 pumps from each side. ⢠thoroughly blend the product and cover the affected area 1-3 times daily. ⢠if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Dosage and Administration:
Directions: clean the skin thoroughly ⢠for new users: apply to a small area once daily for 3 days to test for sensitivity. if no discomfort occurs, dispense 2 pumps from each side. ⢠thoroughly blend the product and cover the affected area 1-3 times daily. ⢠if bothersome dryness or peeling occurs, reduce application to once a day or every other day.
Stop Use:
Warnings: external use only. ⢠irritation and dryness are more likely if you use another topical acne product at the same time. if irritation occurs, use only one product. ⢠avoid contact with eyes. if contact occurs, flush thoroughly with water. ⢠keep out of reach of children. ⢠if swallowed, or if you develop hives, swelling of eyes or mouth, blistering, or difficulty breathing get medical help or contact a poison control center right away.
Package Label Principal Display Panel:
Front: comprehensive acne treatment dermatologist developed for sensitive skin helps clear and prevent acne pimples all skin types 30ml / 1 fl oz developed by dr. rivers back: drug facts medicinal ingredient / ingrediént activ: salicylic acid (acide salicylique)...1.2% directions: clean the skin thoroughly ⢠for new users: apply to a small area once daily for 3 days to test for sensitivity. if no discomfort occurs, dispense 2 pumps from each side. ⢠thoroughly blend the product and cover the affected area 1-3 times daily. ⢠if bothersome dryness or peeling occurs, reduce application to once a day or every other day. mode dâemploi: ⢠appuyer deux fois sur le flacon distributeur et bien mélanger le contenu dans la paume de la main bien propre. ⢠nouveaux utilisateurs : appliquez sur une petite zone, une fois par jour durant 3 jours, pour tester la sensibilité. sâil nây a pas dâinconfort, pompez deux fois de chaque côté. ⢠mélangez soigneusement et appliquez 1 à 3 fois par jour. ⢠si la peau pèle ou sâassèche au point que cela devienne inconfortable, diminuez le nombre d'application à une fois par jour ou tous les deux jours. warnings: external use only. ⢠irritation and dryness are more likely if you use another topical acne product at the same time. ⢠if irritation occurs, use only one product. ⢠avoid contact with eyes. if contact occurs, flush thoroughly with water. ⢠keep out of reach of children. ⢠if swallowed, or if you develop hives, swelling of eyes and mouth, blistering, or difficulty breathing get medical help or contact a poison control center right away. mises en garde: pour un usage externe seulement. ⢠lorsque vous utilisez ce produit, il est plus probable que la peau sâassèche et sâirrite si vous utilisez un autre médicament topique contre lâacné en même temps. si de lâirritation se produit, nâutilisez quâun seul médicament topique contre lâacné à la fois. ⢠Ãvitez le contact avec les yeux. ⢠si un contact survient, rincez abondamment avec de lâeau. ⢠tenez hors de portée des enfants. ⢠si vous ingérez du produit, obtenez immédiatement des soins médicaux ou appelez un centre anti-poison. ⢠obtenez immédiatement des soins médicaux si le produit vous donne de lâurticaire, si vous avez les yeux et la bouche qui enflent, si vous présentez des boursouflures ou si vous avez des difficultés à respirer. cessez lâutilisation et consultez un médecin si votre peau devient extrêmement irritée ou si vous éprouvez une sensation de brûlure ou de démangeaisons. garder hors de la portée des enfants. en cas dâingestion, obtenir des soins médicaux immédiatement. skincare made in canada distributed by: riversol skincare v6a 1a4 canada | questions? 1.866.774.8377 | riversol.com comprehensive acne treatment primary packaging