Label: MATTIFYING TONIC JAFRA- salicylic acid liquid

  • 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 June 22, 2020

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients                       Purpose

    Salicylic Acid 0.5%                 Acne Treatment

    Uses: Treats Acne

    Helps prevent new acne pimples

    Keep out of reach of children

    When using this product

    Using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.

    Warnings

    For external use only.

    If swallowed, get medical help or contact a Poison Control Center right away.

    Directions
    Clean the skin thoroughly before applying.
    Cover the entire affected area with a thin layer 1 to 3 times daily.
    Avoid contact with eyes
    Because excessive drying of the skin may occur, start with 1 application daily, then gradually increase to 2 or 3 times daily if needed or as directed by a doctor.
    If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

    Inactive ingredients: Acrylates Copolymer, Benzophenone-4, Butylene Glycol, Diazolidinyl Urea, Fragrance/parfum, Glycerin, Iodopropynyl  Butylcarbamate, Kaolin, Propylene Glycol, SD Alcohol 40-B/Alcohol denat., Sodium PCA, Water/Aqua, Zinc Gluconate, Zinc Oxide/CI77947

  • PRINCIPAL DISPLAY PANEL

    carton

    Jafra Mattifying Tonic
    Locion Facial Matificante

    200 ml 6.7 Fl Oz

  • INGREDIENTS AND APPEARANCE
    MATTIFYING TONIC   JAFRA
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    SULISOBENZONE (UNII: 1W6L629B4K)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    KAOLIN (UNII: 24H4NWX5CO)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    WATER (UNII: 059QF0KO0R)  
    ZINC GLUCONATE (UNII: U6WSN5SQ1Z)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68828-102-011 in 1 CARTON06/19/2012
    1200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/19/2012
    Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
    Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-102)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!