Label: GLYTONE ACNE SELF-FOAMING CLEANSER- salicylic acid gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 19, 2024

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  • INACTIVE INGREDIENT

    Water, Methyl Perfluoroisobutyl Ether, Butylene Glycol, Sorbitol, Methyl Perfluorobutyl Ether, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Chondrus Crispus (Carrageenan), Cyclopentasiloxane, Cyclohexasilioxane, Sodium Cocamidopropyl PG-Dimonium Chloride Phosphate, Polyhydroxystearic acid, Isononyl Isononanoate, Ethylhexyl Isononanoate, Xanthan Gum, Sodium Hydroxide, Perfluorohexane, o-Cymen-5-ol, Tetrasodium EDTA, Cinnamomum Zeylanicum Bark Extract, Oryza Sativa (Rice) Bran Extract, Yeast Polysaccharides, Blue 1 (CI 42090)

  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Salicylic Acid 0.5% Acne Treatment

  • PURPOSE

    Acne treatment

  • INDICATIONS & USAGE

    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

    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.
    • avoid contact with eyes. If eye contact occurs, rinse thoroughly with water.

    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.

  • DOSAGE & ADMINISTRATION

    Directions

    • At initial use, turn pump head counter-clockwise to unlock.
    • Dispense a small amount into your hand and mix with a little water.
    • Apply a thin layer over entire affected area in a circular motion and rinse thoroughly with warm water two times daily. For a mask-like effect, leave on for 30 seconds before rinsing.
    • Because of excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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.
  • PRINCIPAL DISPLAY PANEL

    Acne Self Foaming CleanserGlytone Acne Self-Foaming Cleanser

    0.5 salicylic acid

    non-irritating formula

    180 ml/6.1 fl oz

  • INGREDIENTS AND APPEARANCE
    GLYTONE ACNE SELF-FOAMING CLEANSER 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-719
    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
    .BETA.-ELEOSTEARIC ACID (UNII: LA17B88161)  
    ORYZA SATIVA WHOLE (UNII: 84IVV0906Z)  
    CITRUS FRUIT (UNII: XDK00Z8012)  
    1-CHLORO-2-METHYL-1-PROPENE (UNII: JP8N4M44OP)  
    LIMONENE DIEPOXIDE (UNII: M6TUW5WEJ9)  
    2-PHENYLPROPANAL PROPYLENE GLYCOL ACETAL (UNII: 1ZRR9A405A)  
    SODIUM HYDROXYPROPYLSULFONATE LAURYLGLUCOSIDE-7 CROSSPOLYMER (UNII: K9R4VJQ1IB)  
    1,3-PROPANEDIOL BIS(4-AMINOBENZOATE) (UNII: 8860R9ORQR)  
    ISOSTEARAMIDOPROPYL ETHYLDIMONIUM ETHOSULFATE (UNII: U059JNZ17L)  
    ISOEICOSANE (UNII: AR294KAG3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DICLOFENAC SODIUM (UNII: QTG126297Q)  
    ACRYLATES CROSSPOLYMER-6 (UNII: 4GXD0Q3OS3)  
    POLYGLUCOSE SORBITOL CARBOXYMETHYL ETHER (UNII: Y8P5S7CF2S)  
    CARBAZOCHROME SODIUM SULFONATE HYDRATE (UNII: Y6G4426VGB)  
    BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES (UNII: 0C9AC7D6XU)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    COCAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE (UNII: H2KVQ74JM4)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    OLEA EUROPAEA FLOWER (UNII: 498M34P1VZ)  
    ETHYL PERFLUOROISOBUTYL ETHER (UNII: G60AS0OTNS)  
    DIMETHICONE PEG-8 ADIPATE (UNII: 09Y0SJ39VP)  
    CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
    ACETYL ARGININE (UNII: TQ7DL04CAE)  
    ETHYL PERFLUOROBUTYL ETHER (UNII: 520BW6FQ5U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    1,3-BUTYLENE GLYCOL 1-PROPIONATE (UNII: 17U77WTV66)  
    MALTOOLIGOSYL GLUCOSIDE (UNII: N91S91EFOG)  
    INDOL-3-YL SODIUM PHOSPHATE (UNII: P1W2D6403E)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    LAMINARIA DIGITATA HYDROLYZED ALGINIC ACID (UNII: 9E3P882579)  
    DISODIUM LAUROYL GLUTAMATE (UNII: O99ROV57IA)  
    CETEARYL METHICONE (15000 MW) (UNII: VY9RTR7MSY)  
    PEG-120 GLYCERYL STEARATE (UNII: 6941286E4I)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)  
    HYDROGENATED STARCH HYDROLYSATE (UNII: 27F77DSJ5V)  
    DISODIUM ASCORBYL SITOSTANOL PHOSPHATE (UNII: 3H8J8917AA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64760-719-011 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00611/09/202001/22/2025
    Labeler - Pierre Fabre USA Inc. (117196928)
    Registrant - Pierre Fabre USA Inc. (117196928)
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