Label: ANTI-BLEMISH CLEANSER- salicylic acid cream

  • 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 July 17, 2016

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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 thoroughly 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

    -Wet face, squeeze into hands and apply to face

    -Gently massage all over face avoiding eye area

    -Rinse thoroughly with water

    -Recommended for daily use

  • STORAGE AND HANDLING

    Other information  store at room

    temperature 68 - 86 F (20 - 30 C)

  • INACTIVE INGREDIENT

    Inactive ingredients  water, cetearyl alcohol, glycerin,

    ppg-15 stearyl ether, ethylhexyl palmitate, steareth-21, potassium

    cetyl phosphate, polysorbate 60, xanthan gum, disodium EDTA,

    methanol, benzalkonium chloride, sodium hydroxide, fragrance

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ANTI-BLEMISH CLEANSER 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58194-054
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    steareth-21 (UNII: 53J3F32P58)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHANOL, (((1-METHYL-2-(5-METHYL-3-OXAZOLIDINYL)ETHOXY)METHOXY)METHOXY)- (UNII: S78T1JQV6B)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58194-054-01113 g in 1 TUBE; Type 0: Not a Combination Product07/17/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D07/17/2016
    Labeler - Shanghai Weierya Daily Chemicals Factory (420359333)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Weierya Daily Chemicals Factory420359333manufacture(58194-054)
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