FDA.reportPublic FDA data

Granex Foam Acne Treatment

Manufacturer
Catalysis, SL
Effective date
2018-01-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:08

Label at a glance#

ProductGranex Foam Acne Treatment
Active ingredientSALICYLIC ACID
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

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

BottleBottle

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • 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 SECTION

  • 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 SECTION

  • 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

OTC - PURPOSE SECTION

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

OTC - QUESTIONS SECTION

+ 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 SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Granex Foam Anti Acne Treatment

BoxBox

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
64539-008-022020-01-31C16284748780-19d75b9d0-68c5-f424-e053-dadaa90a57ceGranex Foam Acne Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64539-008-01Granex Foam Acne Treatment50 mL in 1 BOTTLEAEROSOL, FOAM501
64539-008-02Granex Foam Acne Treatment1 in 1 BOXAEROSOL, FOAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64539-008GRANEX FOAM ACNE TREATMENT (SALICYLIC ACID) AEROSOL, FOAM [CATALYSIS, SL]1Legacy NDC, 2 package rows20180115_62b5342d-5f52-43c7-e053-2991aa0a92d7.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64539-00864539-008-01, 64539-008-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLENE GLYCOL3XUS85K0RAIACT
BIOTIN6SO6U10H04IACT
PEG/PPG-20/6 DIMETHICONEPWZ7N4UIKEIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ALOEV5VD430YW9IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
PANTHENOLWV9CM0O67ZIACT
GLYCYRRHIZIN6FO62043WKIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
ISOBUTANEBXR49TP611IACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SALICYLIC ACIDO414PZ4LPZACTIB
PROPANEDIOL5965N8W85TIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
ALCOHOL3K9958V90MIACT
IRIS X GERMANICA NOTHOVAR. FLORENTINA ROOTM30XO5X4XDIACT
ZINC SULFATE89DS0H96TBIACT
WATER059QF0KO0RIACT
ARCTIUM MINUS ROOTIS8QAQ61Q5IACT
CITRUS X LIMON FRUIT OIL0HNC1J1YEDIACT
POLYSORBATE 207T1F30V5YHIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM SULFITEVTK01UQK3GIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
62b5342d-5f53-43c7-e053-2991aa0a92d762b5342d-5f52-43c7-e053-2991aa0a92d72018-01-13WarningsExact identifier
spl id: 62b5342d-5f53-43c7-e053-2991aa0a92d7
spl set id: 62b5342d-5f52-43c7-e053-2991aa0a92d7

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.