RIVERSOL COMPREHENSIVE ACNE TREATMENT- salicylic acid lotion 
Riversol Skincare Solutions Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

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.

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. •

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.

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 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

RIVERSOL COMPREHENSIVE ACNE TREATMENT 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72019-0002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.18 g  in 30 g
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72019-0002-11 in 1 BOX03/01/2020
130 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart358B03/01/2020
Labeler - Riversol Skincare Solutions Inc (203514773)
Establishment
NameAddressID/FEIBusiness Operations
Cosmaceutical Research Laboratory Inc256797309manufacture(72019-0002)

Revised: 3/2022
Document Id: db8c290a-97a3-0ef9-e053-2a95a90a02ff
Set id: 9ee25c7a-9815-6269-e053-2995a90aca8e
Version: 2
Effective Time: 20220331
 
Riversol Skincare Solutions Inc