Otc - Active Ingredient
Salicylic Acid 0.7%...............................Anti Acne
Bottle (Granexbottle)
Granex Foam Acne Treatment
FDA Label NDC 64539-008
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Catalysis, Sl for the product Granex Foam Acne Treatment (NDC 64539-008). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - keep out of reach of children, warnings, indications & usage, otc - purpose, otc - questions, other safety information, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - Purpose
For the management (or treatment) of Acne
Helps clear up acne blemishes, acne pimples, blackheads
Otc - 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
Package Label.Principal Display Panel
Granex Foam Anti Acne Treatment
Box (Granexbox)
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