Label: ACNE TREATMENT PADS- salicylic acid patch

  • 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 23, 2017

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  • ACTIVE INGREDIENT

    Active ingredient

    Salicylic acid 2%

  • PURPOSE

    Purpose

    Acne treatment

  • INDICATIONS & USAGE

    Uses  for the treatment of acne

  • WARNINGS

    Warnings

    For external use only.

    Avoid contact with eyes & lip, if contact

    occurs, flush throoughly with water.

    Ask a doctor or pharmacist before using

    other topical acne medications at the same time

    or immediately following use of this product. May increase

    dryness or irritation of the skin. If this occurs, only one

    medication should be usedunless directed

    by a doctor.

    When using this product apply to affected

    area only. Do not use on broken skin or

    apply to large areas of the body.

  • 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

    •Cleanse the skin thoroughly before applying medication

    •Use the pad to wipe the entire affected area one to three times daily

    •If bothersome dryness or peeling occurs, reduce application to once a day or every other day

    Do not peave pad on skin for an extended period of time.

  • STORAGE AND HANDLING

    Other information  store at room

    temperature 68 - 86 F (20 - 30 C)

  • INACTIVE INGREDIENT

    Inactive ingredients  water,

    alcohol, glycerin, trideceth - 8,

    PEG-12 dimethicone, hamamelis virginiana

    (witch hazel) flower water, disodium EDTA,

    benzalkonium chloride, sodium hydroxide,

    fragrance

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ACNE TREATMENT PADS 
    salicylic acid patch
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71537-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIDECETH-8 (UNII: FZH06801NX)  
    PEG-12 DIMETHICONE (UNII: ZEL54N6W95)  
    HAMAMELIS VIRGINIANA FLOWER WATER (UNII: 222MYC9QUV)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71537-001-0250 in 1 CONTAINER06/23/2017
    1NDC:71537-001-012 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D06/23/2017
    Labeler - Huijing (Shanghai) Bio-tech Co., Ltd (544482337)
    Establishment
    NameAddressID/FEIBusiness Operations
    Huijing (Shanghai) Bio-tech Co., Ltd544482337manufacture(71537-001)
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