Label: GRANEX FOAM ACNE TREATMENT- salicylic acid aerosol, foam
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Contains inactivated NDC Code(s)
NDC Code(s): 64539-008-01, 64539-008-02 - Packager: Catalysis, SL
- 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 13, 2018
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- KEEP OUT OF REACH OF CHILDREN
- WARNINGS
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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
- QUESTIONS
- OTHER SAFETY INFORMATION
- DOSAGE & ADMINISTRATION
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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
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INGREDIENTS AND APPEARANCE
GRANEX FOAM ACNE TREATMENT
salicylic acid aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64539-008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 0.7 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:64539-008-02 1 in 1 BOX 01/11/2018 1 NDC:64539-008-01 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 01/11/2018 Labeler - Catalysis, SL (862795119) Registrant - Catalysis, SL (862795119) Establishment Name Address ID/FEI Business Operations Catalysis, SL 862795119 manufacture(64539-008)
