Label: VMV HYPOALLERGENICS ID SKIN-BUFFING CLEANSING SCRUB- salicylic acid emulsion

  • 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 11, 2017

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

  • ACTIVE INGREDIENT


    Active Ingredient
    Salicylic Acid 1.00%

  • PURPOSE

    Purpose
    Acne Treatment

  • WARNINGS

    Warnings
    For external use only

  • WHEN USING

    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


    Keep out of reach of children,

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

  • DOSAGE & ADMINISTRATION

    Directions
    - 2x-a-day, massage a small
    amount onto wet skin. Rinse well.
    - Because excessive drying of the
    skin may occur, start with one
    application daily, then gradually
    increase to two or three 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.

  • 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
    Aqua/Water/Eau, Butylene Glycol,
    Camellia Sinensis Leaf Extract,
    Caprylyl Glycol, Cocos Nucifera (Coconut) Oil
    Disodium Laureth Sulfosuccinate, Glycerin, Glyceryl Laurate,
    Glyceryl Stearate, 1,2-Hexanediol, Paraffin, Pumice
    Sodium Laureth Sulfate, Sodium Phytate, Stearic Acid, Stearyl Alcohol

  • 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.

  • CLINICAL STUDIES

    Clinical studies

  • INDICATIONS & USAGE

    Purpose
    Acne Treatment

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

  • PRINCIPAL DISPLAY PANEL

    Principal Display Panel


    id
    SKIN-BUFFING
    CLEANSING SCRUB

    cleansing
    for treated skin

    mild, pH-adjusted, gently
    exfoliating cleanser for
    skin undergoing active
    treatments

    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% SLS + Allergen-Surfactant-Free.

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

    Usage + Patch Tested.

    Non-Comedogenic. Non-Drying.

    For All Skin Types.

    For Men + Women.

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

  • INGREDIENTS AND APPEARANCE
    VMV HYPOALLERGENICS ID SKIN-BUFFING CLEANSING SCRUB 
    salicylic acid emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69774-551
    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
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    12-(9-ANTHROYLOXY)STEARIC ACID (UNII: 039Y7Q32CO)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69774-551-021 in 1 BOX05/15/2017
    1120 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D05/15/2017
    Labeler - SKIN SCIENCES LABORATORY INC. (718777360)
    Establishment
    NameAddressID/FEIBusiness Operations
    SKIN PRESCRIPTIVES MARKETING, INC.718955750manufacture(69774-551)