Label: RIVERSOL COMPREHENSIVE ACNE TREATMENT- salicylic acid lotion

  • 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.

  • 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

    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

  • INGREDIENTS AND APPEARANCE
    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)