Medicinal Ingredient / Ingrédient Médicinal:
Salicylic acid (acide salicylique).... 0.6%
The following Structured Product Label (SPL) was submitted to the FDA by Riversol Skincare Solutions Inc for the product Riversol Comprehensive Acne Treatment (NDC 72019-0002). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding medicinal ingredient / ingrédient médicinal:, directions:, warnings:, dosage & administration, non-medical ingredients, warnings, otc - purpose, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Salicylic acid (acide salicylique).... 0.6%
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, thoroughly mix two pumps into the palm of a clean hand and cover affected area 1-3 times daily. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
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.
Clean the skin thoroughly • For new users:
Apply to small area once daily for 3 days to
test for sensitivity. If no discomfort occurs,
thoroughly mix two pumps into the palm of
a clean hand and cover 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 /
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
• Keep out of reach
of children. •
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.
For the management of acne
Apply to small area once daily for 3 days to
test for sensitivity. If no discomfort occurs,
thoroughly mix two pumps into the palm of
a clean hand and cover affected area 1-3
times daily. If bothersome dryness or
peeling occurs, reduce application to once
a day or every other day.
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Comprehensive Acne Treatment Dermatologist developed for sensitive skin Helps clear and prevent acne pimples All skin types 30ml / 1 fl oz pH 4.5 Developed by Dr. Rivers
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Drug Facts Medicinal Ingredient / Ingrédient médicinal: Salicylic acid (acide salicylique).... 0.6% 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, thoroughly mix two pumps into the palm of a clean hand and cover 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: Nettoyer la peau soigneusement avant d’appliquer ce produit. • Appuyer deux fois sur le flacon distributeur et bien mélanger le contenu dans la paume de la main bien propre. • Recouvrir la zone touchée d’une mince couche, de une à trois fois par jour. Puisque la peau peut devenir sèche, débuter par une application par jour, pour ensuite augmenter graduellement à deux ou à trois fois par jour s’il y a lieu • Si la peau pèle ou s’assèche au point que cela devienne agaçant, diminuer le nombre d’applications 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 or 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 antipoison. • 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 o`u si vous avez de la difficulté 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. Skincare made in Canada Distributed by: Riversol Skincare V6A 1A4 Canada | Questions? 1.866.774.8377 | riversol.com
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