Granex Foam Acne Treatment

Drug Labeling and Warnings

Drug Details [pdf]

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

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  • 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.

  • 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

  • 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

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

  • keep the product in a cool and dry place

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

Aqua, Isobutane, Propylene Glycol, PEG-8 Caprylic/Capric Glycerides, Citrus Limon Fruit Water, Propane , Butylene Glycol, Propanediol, Phenoxyethanol , Salicylic Acid, PEG/PPG-20/6 Dimethicone, Polysorbate 20, Sodium Benzoate, Potassium Sorbate, Panthenol, Aloe Barbadensis Leaf Extract, Cocamidopropyl Betaine, Alcohol, DMDM Hydantoin, Ethylhexylglycerin, AMMONIUM GLYCYRRHIZATE, Iris Florentina Root Extract, Arctium Majus Root Extract, Zinc Sulfate, Butane Retinyl Palmitate, Biotin, Citric Acid., Ascorbic Acid, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate , Sodium Sulfite , Triisopropanolamine, Parfum

Granex Foam Anti Acne Treatment

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GRANEX FOAM ACNE TREATMENT 
salicylic acid aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 64539-012
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
DIMETHYL DISULFIDE (UNII: 3P8D642K5E) 0.024 mg  in 1 mL
LIQUID PETROLEUM (UNII: 6ZAE7X688J) 1.41 mg  in 1 mL
PEG-8 CAPRYLIC/CAPRIC GLYCERIDES (UNII: 00BT03FSO2) 2.7 mg  in 1 mL
BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 1.372 mg  in 1 mL
BIOTIN (UNII: 6SO6U10H04) 0.113 mg  in 1 mL
PEG/PPG-20/6 DIMETHICONE (UNII: PWZ7N4UIKE) 0.612 mg  in 1 mL
PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.821 mg  in 1 mL
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.091 mg  in 1 mL
ALOE (UNII: V5VD430YW9) 0.447 mg  in 1 mL
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) 0.009 mg  in 1 mL
ASCORBIC ACID (UNII: PQ6CK8PD0R) 0.068 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) 0.405 mg  in 1 mL
ISOBUTANE (UNII: BXR49TP611) 4.566 mg  in 1 mL
POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.45 mg  in 1 mL
PROPANEDIOL (UNII: 5965N8W85T) 0.877 mg  in 1 mL
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.1125 mg  in 1 mL
ALCOHOL (UNII: 3K9958V90M) 0.405 mg  in 1 mL
IRIS X GERMANICA NOTHOVAR. FLORENTINA ROOT (UNII: M30XO5X4XD) 0.675 mg  in 1 mL
ZINC SULFATE (UNII: 89DS0H96TB) 0.032 mg  in 1 mL
WATER (UNII: 059QF0KO0R) 74.134 mg  in 1 mL
ARCTIUM MINUS ROOT (UNII: IS8QAQ61Q5) 0.0045 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) 0.457 mg  in 1 mL
SODIUM SULFITE (UNII: VTK01UQK3G) 0.45 mg  in 1 mL
1,2-PROPANEDIAMINE (UNII: 2A4P522UGO) 1.41 mg  in 1 mL
TRIISOPROPANOLAMINE (UNII: W9EN9DLM98) 0.0018 mg  in 1 mL
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS) 0.0054 mg  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 64539-012-021 in 1 BOX01/11/2018
1NDC: 64539-012-011 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/11/201801/01/2019
Labeler - Catalysis, SL (862795119)
Registrant - Catalysis, SL (862795119)
Establishment
NameAddressID/FEIBusiness Operations
Catalysis, SL862795119manufacture(64539-012)

Revised: 6/2019
Document Id: 8a539ab8-b463-05c1-e053-2a95a90ac33c
Set id: 65327f13-3d1a-034c-e053-2a91aa0ab52c
Version: 4
Effective Time: 20190602
 
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