Label: GLYTONE ACNE BACK AND CHEST TREATMENT- salicylic acid spray
GLYTONE ACNE TREATMENT- salicylic acid spray

  • NDC Code(s): 64760-711-01, 64760-711-02, 64760-735-01
  • Packager: Pierre Fabre USA Inc.
  • 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 January 2, 2023

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  • Drug Facts

  • Active Ingredients

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Use

    For the treatment of acne.

    • Dries and clears acne blemishes and allows skin to heal.
    • Penetrates pores to eliminate most acne blemishes, blackheads, and whiteheads.
    • Helps prevent the development of new acne blemishes, blackheads, and whiteheads.
  • Warnings

    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 use only one topical acne medication at a time.
    • Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.
    • Spray in a well ventilated area. Do not inhale.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children.

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

  • Directions

    Spray directly onto cleansed affected areas of the back, shoulders and chest by holding 3 to 6 inches away from the skin one to three times daily.

    Pump works upside down and for optimal application.

    Let dry prior to putting on clothes.

    Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two to three times daily if needed or as directed by a doctor.

  • Inactive Ingredients

    AQUA (WATER), ALCOHOL DENAT., METHYLPROPANEDIOL, GLUCONOLACTONE, POLYSORBATE 20, POTASSIUM SORBATE, SODIUM GLUCONATE, SODIUM BENZOATE, CITRIC ACID, GLYCERIN, HIBISCUS SARBARIFFA FLOWER EXTRACT, CENTELLA ASIATICA (GOTU KOLA) LEAF EXTRACT, CAMELLIA SINENSIS (WHITE TEA) LEAF EXTRACT, CAMELLIA OLEIFERA (GREEN TEA) LEAF EXTRACT, ALOE BARBADENSIS LEAF JUICE POWDER, SODIUM HYDROXIDE

  • PRINCIPAL DISPLAY PANEL

    GLYTONE

    Acne Back & Chest Treatment Spray

    ACNE THERAPY

    2% Salicylic Acid Acne Medication Gluconolactone (PHA) Aloe

    240 mL / 8.0 FL. OZ.

    label

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    GLYTONE ACNE BACK AND CHEST TREATMENT 
    salicylic acid spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-735
    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
    HIBISCUS SABDARIFFA FLOWER (UNII: 45TGG6IU6M)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CALCIUM GLUCONATE (UNII: SQE6VB453K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64760-735-011 in 1 CARTON09/01/2021
    1240 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H09/01/2021
    GLYTONE ACNE TREATMENT 
    salicylic acid spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-711
    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
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64760-711-01240 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/06/201806/22/2023
    2NDC:64760-711-0260 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product03/06/201806/22/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D03/06/201806/22/2023
    Labeler - Pierre Fabre USA Inc. (117196928)
    Registrant - Pierre Fabre USA Inc. (117196928)
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