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NDC 72019-0002-01 Riversol Comprehensive Acne Treatment 0.18 g/30g Details
Riversol Comprehensive Acne Treatment 0.18 g/30g
Riversol Comprehensive Acne Treatment is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Riversol Skincare Solutions Inc. The primary component is SALICYLIC ACID.
MedlinePlus Drug Summary
Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or birthmarks. Salicylic acid is in a class of medications called keratolytic agents. Topical salicylic acid treats acne by reducing swelling and redness and unplugging blocked skin pores to allow pimples to shrink. It treats other skin conditions by softening and loosening dry, scaly, or thickened skin so that it falls off or can be removed easily.
Related Packages: 72019-0002-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical
Product Information
NDC | 72019-0002 |
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Product ID | 72019-0002_db8c290a-97a3-0ef9-e053-2a95a90a02ff |
Associated GPIs | |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Riversol Comprehensive Acne Treatment |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Salicylic Acid |
Product Type | HUMAN OTC DRUG |
Dosage Form | LOTION |
Route | TOPICAL |
Active Ingredient Strength | 0.18 |
Active Ingredient Units | g/30g |
Substance Name | SALICYLIC ACID |
Labeler Name | Riversol Skincare Solutions Inc |
Pharmaceutical Class | n/a |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part358B |
Listing Certified Through | 2023-12-31 |
Package
Package Images

NDC 72019-0002-01 (72019000201)
NDC Package Code | 72019-0002-1 |
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Billing NDC | 72019000201 |
Package | 1 BOTTLE, PUMP in 1 BOX (72019-0002-1) / 30 g in 1 BOTTLE, PUMP |
Marketing Start Date | 2020-03-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL 9ee25c7a-9815-6269-e053-2995a90aca8e Details
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.
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.
SPL UNCLASSIFIED 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
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
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
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.
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 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
INGREDIENTS AND APPEARANCE
RIVERSOL COMPREHENSIVE ACNE TREATMENT
salicylic acid lotion |
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Labeler - Riversol Skincare Solutions Inc (203514773) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
---|---|---|---|
Cosmaceutical Research Laboratory Inc | 256797309 | manufacture(72019-0002) |