Label: ID ANTI-ACNE TONER CLARIFYING FACE PLUS BODY TREATMENT- 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 May 15, 2017

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  • ACTIVE INGREDIENT

    Active Ingredients
    Salicylic Acid 1.00%

  • PURPOSE

    Purpose
    Acne Treatment

  • INDICATIONS & USAGE

    Purpose
    Acne Treatment

    Uses
    - Treats acne
    - Hepls prevent development of new acne blemishes

  • WARNINGS

    Warnings

    For external use only

    When using this product
    - Apply to affected areas only
    - Avoid unnecessary sun exposure and use a sunscreen
    - Do not use in or near the eyes
    - Using other topical acne drugs at the same time
    or right after use of this product
    may increase dryness or irritation of the skin.
    Only one drug should be used unless directed by a doctor

    Keep out of reach of children, if
    swallowed, get medical help or contact a Poison Control Center
    right away.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children, if
    swallowed, get medical help or contact a Poison Control Center
    right away.

  • DOSAGE & ADMINISTRATION

    Directions
    - Clean skin well before applying this product
    - Moisten (do not soak) cotton with this product.
    - Swipe gently over affected areas on face and
    body skin. Avoid mucosal (wet) areas of eyes,
    nostrils and mouth
    - Follow with a sunscreen
    - Because excessive drying of the skin may
    occur, start applying 2x-a-week only, very slowly
    increasing until 2x-a-day usage is achieved (no
    earlier than week 8). Do not rush.
    - If bothersome dryness or peeling occurs, stop
    for 5-7 days and restart application frequency at
    2x-a-week, slowly increasing over several weeks.

  • STORAGE AND HANDLING


    - Protect the product in this container from excessive heat and direct sun.
    - Before use, test a tiny amount on skin (we omit allergens, but you may be sensitive
    to an ingredient that is not an allergen.
    - Introduce new skin products one at a time, with at least 3 days in between.
    - Do not (re)introduce removed portions of product or other substances into container.

  • INACTIVE INGREDIENT

    Inactive ingredients
    Alcohol, Aqua/Water/Eau, Butylene Glycol,
    Camellia Sinensis Leaf Extract, Gyceryl Laurate,
    Hamamelis Virginiana Water, PEG-40 Castor Oil,
    Sodium Phytate, Tromethamine

  • OTHER SAFETY INFORMATION

    Notes: If contact with eyes
    occurs, flush out with plenty of
    water. This product is meant to be washed off quickly, not left on the
    skin for longer than a few seconds
    while cleansing. Prolonged
    exposure without rinsing
    immediately may cause irritation to
    skin. Stop use and consult your
    doctor in the unlikely event of
    discomfort or sensitivity. 1ST-TIME
    USERS: Some first-time users may
    experience an initial acne
    break-out due to the deeper
    exfoliation of the pores' inner
    walls. If your pores have not been
    regularly cleaned at this level,
    existing pore cloggers are brought
    to the surface. As therapy
    continues, this deeper-cleaned
    state is maintained and acne is
    markedly reduced. With correct
    use - following instructions
    carefully, the slow increase in
    application frequency, the use of
    hypoallergenic, non-comedogenic
    and pH-appropriate support
    products in the Id system - as well
    as prevention with non-comedo-
    genic products such as Essence
    Skin-Saving Hair, Body + Bath Care,
    Armada Sun + Light Screens,
    Skintelligent Beauty Makeup, this
    initial reaction soon disappears. If it
    does occur, stop use for 1 week
    and restart therapy at the
    beginning, with 2x-a-week
    applications. CYSTIC ACNE can
    be internally caused. If you have
    cystic acne, consult your
    dermatologist as you may need
    additional medication and/or other
    management.

  • PRINCIPAL DISPLAY PANEL

    PDP

    ID TONER

    VMV HYPOALLERGENICS
    validated hypoallergenic.
    randomized, blinded, published &
    awarded clinical studies. since 1979

    Id
    ANTI-ACNE TONER
    Face + body
    Clarifier

    Salicylic acid + monolaurin + witch hazel;
    antioxidants : green tea + rice phytic acid
    clarifying , smoothening + exfoliating system

    Validated
    Hypoallergenic:
    VH -109/109
    sans all common allergens,
    extended allergen series:
    North American Contact Dermatitis
    Group + European Surveillance
    System on Contact Allergies

    100% All-Types-Of-Fragrance-Free.

    100% Dye, Phthalate, Paraben + Preservative-Free.

    Usage, Patch + Clinically-Tested (in vitro + in vivo; evidence-based:
    double-blind, randomized).

    Non-Comedogenic. Non-Drying.

    For All Skin Types.

    For Men + Women, 18+.

    120 mL (4 Fl. Oz.) - 120 mL

  • INGREDIENTS AND APPEARANCE
    ID ANTI-ACNE TONER CLARIFYING FACE PLUS BODY TREATMENT 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69774-552
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.2 g  in 120 mL
    Inactive Ingredients
    Ingredient NameStrength
    TROMETHAMINE (UNII: 023C2WHX2V)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    ALCOHOL (UNII: 3K9958V90M)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69774-552-031 in 1 BOTTLE04/15/2017
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/15/2017
    Labeler - SKIN SCIENCES LABORATORY INC. (718777360)