GRANEX FOAM ACNE TREATMENT (SALICYLIC ACID) AEROSOL, FOAM [CATALYSIS, SL]

GRANEX FOAM ACNE TREATMENT (SALICYLIC ACID) AEROSOL, FOAM [CATALYSIS, SL]
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NDC 64539-008-01, 64539-008-02
Set ID 62b5342d-5f52-43c7-e053-2991aa0a92d7
Category HUMAN OTC DRUG LABEL
Packager Catalysis, SL
Generic Name
Product Class
Product Number
Application Number PART333D
  • ACTIVE INGREDIENT

    Salicylic Acid 0.7%...............................Anti Acne

    Bottle

  • KEEP OUT OF REACH OF CHILDREN

    • When using this product
    • Avoid contact with eyes
    • Keep out of reach of children. In case of overdose get medical help or Contact a Poison Control Center right away.
  • WARNINGS

    • For external use only
      • 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 used unless directed by a doctor
  • INDICATIONS & USAGE

    • Cleanse the skin thoroughly before applying medication. Cover the entire affected area with a thin layer one to two times daily. Massage for 30 seconds until the foam is absorbed Because excessive drying of the skin may occur. 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

    • "Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above
  • PURPOSE

    For the management (or treatment) of Acne
    Helps clear up acne blemishes, acne pimples, blackheads

  • QUESTIONS

    + 34 913456902 Monday to Friday: 9:00 am to 5:00 pm

  • OTHER SAFETY INFORMATION

    • keep the product in a cool and dry place
  • DOSAGE & ADMINISTRATION

    • Apply a small amount the intimate parts and gently wash. Rinse with water
    • Maybe used as often as necessary
  • INACTIVE INGREDIENT

    Aqua, Isobutane, Butane, Propane, Propylene Glycol, PEG-8 Caprylic/Capric Glycerides, Propanediol, Aqua, Alcohol, Iris Florentina Root Extract, Zinc Sulfate, Retinyl Palmitate, Butylene Glycol, Aqua, Arctium Majus Root Extract, Zinc Sulfate, Biotin, Citrus Limon Fruit Water, PEG/PPG-20/6 Dimethicone, Cocamidopropyl Betaine, Phenoxyethanol, Ethylhexylglycerin, Polysorbate 20, Aloe barbadensis Extract, Citric Acid, Ascorbic Acid, Sodium Benzoate, Potassium Sorbate, Sodium Sulfite , Panthenol, Potassium Sorbate, Sodium Benzoate, Parfum, Glycyrrhizic Acid

  • PRINCIPAL DISPLAY PANEL

    Granex Foam Anti Acne Treatment

    Box

  • INGREDIENTS AND APPEARANCE
    GRANEX FOAM ACNE TREATMENT 
    salicylic acid aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64539-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 2.25 mg  in 1 mL
    BIOTIN (UNII: 6SO6U10H04) 2.25 mg  in 1 mL
    PEG/PPG-20/6 DIMETHICONE (UNII: PWZ7N4UIKE) 1.8 mg  in 1 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg  in 1 mL
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.9 mg  in 1 mL
    ALOE (UNII: V5VD430YW9) 0.45 mg  in 1 mL
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.45 mg  in 1 mL
    ASCORBIC ACID (UNII: PQ6CK8PD0R) 0.45 mg  in 1 mL
    PANTHENOL (UNII: WV9CM0O67Z) 0.45 mg  in 1 mL
    GLYCYRRHIZIN (UNII: 6FO62043WK) 0.09 mg  in 1 mL
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) 1.35 mg  in 1 mL
    ISOBUTANE (UNII: BXR49TP611) 6 mg  in 1 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.45 mg  in 1 mL
    PROPANEDIOL (UNII: 5965N8W85T) 2.25 mg  in 1 mL
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 2.25 mg  in 1 mL
    ALCOHOL (UNII: 3K9958V90M) 2.25 mg  in 1 mL
    IRIS X GERMANICA NOTHOVAR. FLORENTINA ROOT (UNII: M30XO5X4XD) 2.25 mg  in 1 mL
    ZINC SULFATE (UNII: 89DS0H96TB) 2.25 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 2.25 mg  in 1 mL
    ARCTIUM MINUS ROOT (UNII: IS8QAQ61Q5) 2.25 mg  in 1 mL
    CITRUS X LIMON FRUIT OIL (UNII: 0HNC1J1YED) 2.25 mg  in 1 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.54 mg  in 1 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.45 mg  in 1 mL
    SODIUM SULFITE (UNII: VTK01UQK3G) 0.45 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64539-008-021 in 1 BOX01/11/2018
    1NDC:64539-008-0150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/11/2018
    Labeler - Catalysis, SL (862795119)
    Registrant - Catalysis, SL (862795119)
    Establishment
    NameAddressID/FEIBusiness Operations
    Catalysis, SL862795119manufacture(64539-008)

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