FDA Label for Riversol Comprehensive Acne Treatment
View Indications, Usage & Precautions
Riversol Comprehensive Acne Treatment Product Label
The following document was submitted to the FDA by the labeler of this product Riversol Skincare Solutions Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
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.
Dosage & Administration
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
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
• 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.
Otc - Purpose
For the management of acne
Directions
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.
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 pH 4.5 Developed by Dr. Rivers
Back:
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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