RIVERSOL COMPREHENSIVE ACNE TREATMENT- salicylic acid lotion

Riversol Comprehensive Acne Treatment by

Drug Labeling and Warnings

Riversol Comprehensive Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Riversol Skincare Solutions Inc, Cosmaceutical Research Laboratory Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Medicinal Ingredient / Ingrédient médicinal:

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.

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

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

Keep out of reach
of children.

PURPOSE

For the management of acne

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72019-0002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.18 g  in 30 g

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 60 (UNII: CAL22UVI4M)
OCTYLDODECANOL (UNII: 461N1O614Y)
1,9-DECADIENE (UNII: 2KWZ01G244)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SODIUM NITRITE (UNII: M0KG633D4F)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
PEG-100 STEARATE (UNII: YD01N1999R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72019-0002-1	1 in 1 BOX	03/01/2020
1		30 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part358B	03/01/2020

Labeler - Riversol Skincare Solutions Inc (203514773)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmaceutical Research Laboratory Inc		256797309	manufacture(72019-0002)