Label: RIVERSOL COMPREHENSIVE ACNE TREATMENT- salicylic acid lotion
- NDC Code(s): 72019-0002-1
- Packager: Riversol Skincare Solutions Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated March 31, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Medicinal Ingredient / Ingrédient médicinal:
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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.
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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.
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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.
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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
- PURPOSE
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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.
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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
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INGREDIENTS AND APPEARANCE
RIVERSOL COMPREHENSIVE ACNE TREATMENT
salicylic acid lotionProduct 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)