GRANEX FOAM ACNE TREATMENT- salicylic acid aerosol, foam 
Catalysis, SL

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.

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Granex Foam Acne Treatment

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

Bottle

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

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

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

Granex Foam Anti Acne Treatment

Box

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)

Revised: 1/2018
Document Id: 62b5342d-5f53-43c7-e053-2991aa0a92d7
Set id: 62b5342d-5f52-43c7-e053-2991aa0a92d7
Version: 1
Effective Time: 20180113
 
Catalysis, SL