Riversol Comprehensive Acne Treatment

Manufacturer
Riversol Skincare Solutions Inc | Cosmaceutical Research Laboratory Inc
Effective date
2022-03-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:49:07

Label at a glance#

ProductRiversol Comprehensive Acne Treatment
Active ingredientSALICYLIC ACID
Label structure11 sections

Dosage and administration

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.

Label contents#

Full prescribing information#

Medicinal Ingredient / Ingrédient médicinal:

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid (acide salicylique).... 1.2%

Directions:

OTC - WHEN USING SECTION

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.

Warnings:

OTC - STOP USE SECTION

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.

DOSAGE & ADMINISTRATION SECTION

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.

Non-Medical Ingredients

INACTIVE INGREDIENT SECTION


Non-Medical Ingredients /
Ingrédients non médicinaux:
Aqua, Octyldodecanol,
Caprylic/capric triglyceride,
Cetearyl alcohol/Sodium lauryl
sulfate/Sodium cetearyl sulfate,
Polysorbate 60, PVM/MA
Decadiene Crosspolymer,
Acrylates/C10-30 Alkyl Acrylate
Crosspolymer, Xanthan Gum,
Propylene glycol,
Phenoxyethanol, Sodium
hydroxide, Citric acid, Sodium
nitrite, Glyceryl Stearate,
PEG-100

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


• Keep out of reach
of children. •

OTC - PURPOSE SECTION

For the management of acne

Warnings

WARNINGS SECTION



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.

Directions

INDICATIONS & USAGE SECTION

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.

RECENT MAJOR CHANGES SECTION

Section changed: Dosage & administration section. Incorporated 07/2021

Previous text: If no discomfort occurs, thoroughly mix two pumps into the palm of a clean hand and cover affected area 1-3 times daily.

Updated text: If no discomfort occurs, dispense 2 pumps from each side.

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

Comprehensive Acne Treatment primary packagingComprehensive Acne Treatment primary packaging

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 d’emploi: • 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. S’il n’y a pas d’inconfort, pompez deux fois de chaque côté. • Mélangez soigneusement et appliquez 1 à 3 fois par jour. • Si la peau pèle ou s’assèche 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 s’assèche et s’irrite si vous utilisez un autre médicament topique contre l’acné en même temps. Si de l’irritation se produit, n’utilisez qu’un seul médicament topique contre l’acné à la fois. • Évitez le contact avec les yeux. • Si un contact survient, rincez abondamment avec de l’eau. • 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 l’urticaire, si vous avez les yeux et la bouche qui enflent, si vous présentez des boursouflures ou si vous avez des difficultés à respirer. Cessez l’utilisation 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 d’ingestion, obtenir des soins médicaux immédiatement.

Skincare made in Canada Distributed by: Riversol Skincare V6A 1A4 Canada | Questions? 1.866.774.8377 | riversol.com

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199135salicylic acid 0.6 % Topical LotionPSN2
199135salicylic acid 6 MG/ML Topical LotionSCD2
199135salicylic acid 0.6 % Topical LotionSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
70dd82cf-c501-052d-5d98-d42ef9849750Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72019-0002-1Riversol Comprehensive Acne Treatment30 g in 1 BOTTLE, PUMPLOTION302
72019-0002-1Riversol Comprehensive Acne Treatment1 in 1 BOXLOTION12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72019-0002RIVERSOL COMPREHENSIVE ACNE TREATMENT (SALICYLIC ACID) LOTION [RIVERSOL SKINCARE SOLUTIONS INC]2Legacy NDC, 2 package rows20220409_9ee25c7a-9815-6269-e053-2995a90aca8e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72019-000272019-0002-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
db8c290a-97a3-0ef9-e053-2a95a90a02ff9ee25c7a-9815-6269-e053-2995a90aca8e2022-03-31WarningsExact identifier
spl id: db8c290a-97a3-0ef9-e053-2a95a90a02ff
spl set id: 9ee25c7a-9815-6269-e053-2995a90aca8e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.