Label: FRONTMAN FADE- salicylic acid cream, augmented

  • 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 November 17, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Salicylic Acid 0.5%

  • Purpose

    Acne medication

  • Use

    For the treatment of acne.

  • Warnings

    For external use only.

    When using this product

    • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
    • If eye contact occurs, flush thoroughly with water.

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

  • Directions

    • cleanse skin thoroughly before applying this product
    • cover the entire affected area with a thin layer one to three times daily
    • because excessive drying of the skin may occur in rare cases, 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.
  • Other information

    Store at room temperature.

  • Inactive ingredients

    water (aqua / eau), isododecane, titanium dioxide (CI 77891), isohexadecane, polyglyceryl-3 diisostearate, butylene glycol, disteardimonium hectorite, peg-30 dipolyhydroxystearate, silica, iron oxides (CI 77492), vp/hexadecene copolymer, kaolin, propylene carbonate, magnesium sulfate, iron oxides (CI 77491), phenoxyethanol, ethylhexyl palmitate, triethoxycaprylylsilane, cyclodextrin, caprylyl glycol, menthoxypropanediol, iron oxides (CI 77499), glycerin, lactobacillus/lemon peel ferment extract, mentha viridis (spearmint) leaf extract, silica dimethyl silylate, sodium hyaluronate, hexylene glycol

  • Questions?

    Call (213) 214-1242 or visit www.befrontman.com

  • SPL UNCLASSIFIED SECTION

    Dist. by Frontman Inc., Brooklyn, NY 11201. Made in Canada.

  • PRINCIPAL DISPLAY PANEL - 10 ML Tube Carton - NDC 79638-587-01

    FRONTMAN
    FADE

    Acne Fader with salicylic acid
    0.33 Oz (10 ML)

    PRINCIPAL DISPLAY PANEL - 10 ML Tube Carton - NDC 79638-587-01
  • PRINCIPAL DISPLAY PANEL - 10 ML Tube Carton - NDC 79638-588-01

    FRONTMAN
    FADE

    Acne Fader with salicylic acid
    0.33 Oz (10 ML)

    PRINCIPAL DISPLAY PANEL - 10 ML Tube Carton - NDC 79638-588-01
  • PRINCIPAL DISPLAY PANEL - 10 ML Tube Carton - NDC 79638-589-01

    FRONTMAN
    FADE

    Acne Fader with salicylic acid
    0.33 Oz (10 ML)

    PRINCIPAL DISPLAY PANEL - 10 ML Tube Carton - NDC 79638-589-01
  • PRINCIPAL DISPLAY PANEL - 10 ML Tube Carton - NDC 79638-590-01

    FRONTMAN
    FADE

    Acne Fader with salicylic acid
    0.33 Oz (10 ML)

    PRINCIPAL DISPLAY PANEL - 10 ML Tube Carton - NDC 79638-590-01
  • INGREDIENTS AND APPEARANCE
    FRONTMAN FADE 
    salicylic acid cream, augmented
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79638-587
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    isododecane (UNII: A8289P68Y2)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    isohexadecane (UNII: 918X1OUF1E)  
    polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
    butylene glycol (UNII: 3XUS85K0RA)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    peg-30 dipolyhydroxystearate (4000 mw) (UNII: 9713Q0S7FO)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    vinylpyrrolidone/hexadecene copolymer (UNII: KFR5QEN0N9)  
    kaolin (UNII: 24H4NWX5CO)  
    propylene carbonate (UNII: 8D08K3S51E)  
    magnesium sulfate, unspecified form (UNII: DE08037SAB)  
    ferric oxide red (UNII: 1K09F3G675)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    ethylhexyl palmitate (UNII: 2865993309)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    caprylyl glycol (UNII: 00YIU5438U)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    glycerin (UNII: PDC6A3C0OX)  
    spearmint (UNII: J7I2T6IV1N)  
    silica dimethyl silylate (UNII: EU2PSP0G0W)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    hexylene glycol (UNII: KEH0A3F75J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79638-587-011 in 1 CARTON12/01/2020
    110 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D12/01/2020
    FRONTMAN FADE 
    salicylic acid cream, augmented
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79638-588
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    isododecane (UNII: A8289P68Y2)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    isohexadecane (UNII: 918X1OUF1E)  
    polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
    butylene glycol (UNII: 3XUS85K0RA)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    peg-30 dipolyhydroxystearate (4000 mw) (UNII: 9713Q0S7FO)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    vinylpyrrolidone/hexadecene copolymer (UNII: KFR5QEN0N9)  
    kaolin (UNII: 24H4NWX5CO)  
    propylene carbonate (UNII: 8D08K3S51E)  
    magnesium sulfate, unspecified form (UNII: DE08037SAB)  
    ferric oxide red (UNII: 1K09F3G675)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    ethylhexyl palmitate (UNII: 2865993309)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    caprylyl glycol (UNII: 00YIU5438U)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    glycerin (UNII: PDC6A3C0OX)  
    spearmint (UNII: J7I2T6IV1N)  
    silica dimethyl silylate (UNII: EU2PSP0G0W)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    hexylene glycol (UNII: KEH0A3F75J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79638-588-011 in 1 CARTON12/01/2020
    110 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D12/01/2020
    FRONTMAN FADE 
    salicylic acid cream, augmented
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79638-589
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    isododecane (UNII: A8289P68Y2)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    isohexadecane (UNII: 918X1OUF1E)  
    polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
    butylene glycol (UNII: 3XUS85K0RA)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    peg-30 dipolyhydroxystearate (4000 mw) (UNII: 9713Q0S7FO)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    vinylpyrrolidone/hexadecene copolymer (UNII: KFR5QEN0N9)  
    kaolin (UNII: 24H4NWX5CO)  
    propylene carbonate (UNII: 8D08K3S51E)  
    magnesium sulfate, unspecified form (UNII: DE08037SAB)  
    ferric oxide red (UNII: 1K09F3G675)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    ethylhexyl palmitate (UNII: 2865993309)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    caprylyl glycol (UNII: 00YIU5438U)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    glycerin (UNII: PDC6A3C0OX)  
    spearmint (UNII: J7I2T6IV1N)  
    silica dimethyl silylate (UNII: EU2PSP0G0W)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    hexylene glycol (UNII: KEH0A3F75J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79638-589-011 in 1 CARTON12/01/2020
    110 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D12/01/2020
    FRONTMAN FADE 
    salicylic acid cream, augmented
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79638-590
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    isododecane (UNII: A8289P68Y2)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    isohexadecane (UNII: 918X1OUF1E)  
    polyglyceryl-3 diisostearate (UNII: 46P231IQV8)  
    butylene glycol (UNII: 3XUS85K0RA)  
    disteardimonium hectorite (UNII: X687XDK09L)  
    peg-30 dipolyhydroxystearate (4000 mw) (UNII: 9713Q0S7FO)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    vinylpyrrolidone/hexadecene copolymer (UNII: KFR5QEN0N9)  
    kaolin (UNII: 24H4NWX5CO)  
    propylene carbonate (UNII: 8D08K3S51E)  
    magnesium sulfate, unspecified form (UNII: DE08037SAB)  
    ferric oxide red (UNII: 1K09F3G675)  
    phenoxyethanol (UNII: HIE492ZZ3T)  
    ethylhexyl palmitate (UNII: 2865993309)  
    triethoxycaprylylsilane (UNII: LDC331P08E)  
    caprylyl glycol (UNII: 00YIU5438U)  
    3-((l-menthyl)oxy)propane-1,2-diol (UNII: KD6TZ2QICH)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    glycerin (UNII: PDC6A3C0OX)  
    spearmint (UNII: J7I2T6IV1N)  
    silica dimethyl silylate (UNII: EU2PSP0G0W)  
    hyaluronate sodium (UNII: YSE9PPT4TH)  
    hexylene glycol (UNII: KEH0A3F75J)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79638-590-011 in 1 CARTON12/01/2020
    110 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart333D12/01/2020
    Labeler - Wingman Cover LLC (117559654)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetica Laboratories Inc255080491MANUFACTURE(79638-587, 79638-588, 79638-589, 79638-590)
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