Label: WITCH HAZEL PORE CLARIFYING TONER 8 OZ- salicylic acid 2% gel

  • 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 December 11, 2019

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  • PURPOSE

    Purpose

    Acne treatment

  • ACTIVE INGREDIENT

    Active Ingredient

    Salicylic Acid 2%

  • DOSAGE & ADMINISTRATION

    Directions

    • Cleanse skin thoroughly before applying medication.
    • Cover the entire affected area with a thin layer 1 to 3 times daily using a cotton ball or pad.
    • 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

  • 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.

  • INACTIVE INGREDIENT

    Water, alcohol denat., isopropyl alcohol, hamamelis virginiana (witch hazel) water, PEG-40 hydrogenated castor oil, glycerin, fragrance, sodium hydroxide, disodium EDTA, menthol

  • WARNINGS

    Warnings

    For external use only

    Flammable: Keep away from fire or flame

    When using this product

    • Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, oinly use one topical acne medication at a time.
    • Avoid contact with eyes. If contact occurs, rinse thoroughly with water
  • INDICATIONS & USAGE

    Uses

    • Clears up acne blemishes
    • Penetrates pores to control acne blemishes
    • Helps prevent new acne blemishes from forming
  • OTHER SAFETY INFORMATION

    Other Information

    Store at room temperature

    Questions / Comments?

    1-855-345-5575

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    WITCH HAZEL PORE CLARIFYING TONER  8 OZ
    salicylic acid 2% gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58503-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    MENTHOL (UNII: L7T10EIP3A)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58503-121-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product12/11/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D12/11/2019
    Labeler - China Ningbo Shangge Cosmetic Technology Corp. (529287434)
    Establishment
    NameAddressID/FEIBusiness Operations
    China Ningbo Shangge Cosmetic Technology Corp.529287434manufacture(58503-121)
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