Label: ID ANTI ACNE- 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 April 23, 2017

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

  • ACTIVE INGREDIENT

    Active Ingredients

    Salicylic Acid 1.95%

  • PURPOSE

    Purpose

    Acne Treatment

  • INDICATIONS & USAGE

    Uses

    Treats acne • Helps prevent development of new acne blemishes

  • WARNINGS

    Warnings

    For external use only

    When using lhis 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

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

  • DOSAGE & ADMINISTRATION

    Directions

    • Clean Directions skin well before applying this product

    • Dot and spread gently over face, neck, chest, back, back of arms, thighs, posterior and other affected areas. Avoid mucosaI (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

    Other information
    - 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, Inactive Aq !:J,redients ater/Eau, Butylene Glycol, C12-15 Alkyl Lactate, Camellia Sinensis Leaf ElCl:ract, Ceteareth-25, Getearyl Alcohol, Gyclol)entasilox- ane, Glycerin, Glyceryl Caprate, Glyceryl Laurate, Glyceryl Stearate, 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

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

    id
    OIL-FREE
    CLARIFYING LOTION

    face + body anti-acne
    exfoliating hydrator

    salicylic acid+ monolaurin: glycerin; 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+.

    110 mL (3.72 Fl. Oz.) - 110 mL

  • INGREDIENTS AND APPEARANCE
    ID ANTI ACNE 
    salicylic acid lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69774-553
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2.15 g  in 110 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    C12-15 ALKYL LACTATE (UNII: GC844VRD7E)  
    GLYCERYL CAPRATE (UNII: 197M6VFC1W)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69774-553-041 in 1 BOX04/15/2017
    1110 mL in 1 BOTTLE, PUMP; 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)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKIN PRESCRIPTIVES MARKETING, INC.718955750manufacture(69774-553)