Indications & Usage
Medicated, non-whitening lotion helps fight existing acne and prevent future breakouts from forming while calming visible redness.
Glytone Acne Bpo Treatment Gel
FDA Label NDC 84262-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Glytone, Llc for the product Glytone Acne Bpo Treatment Gel (NDC 84262-030). 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 indications & usage, otc - active ingredient, otc - purpose, warnings, inactive ingredient, dosage & administration, otc - keep out of reach of children, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
BENZOYL PEROXIDE 5%
Otc - Purpose
BENZOYL PEROXIDE 5% - prevent future breakouts from forming while calming visible redness.
Warnings
For external use only.
Do not use:
- on damaged or broken skin.
- as a sunscreen for sunbathing.
When using this product:
- keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if:
- rash occurs.
Keep out of reach of children.
Do not swallow. If swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredient
WATER (AQUA), PROPANEDIOL, DIMETHYL ISOSORBIDE, BUTYLENE GLYCOL, GLYCERIN, 1,2-HEXANEDIOL, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOHEXADECANE, HYDROXYACETOPHENONE, POLYSORBATE 80, POLYGLYCERYL-2 ISOSTEARATE, XANTHAN GUM, ENANTIA CHLORANTHA BARK EXTRACT, SODIUM CITRATE, TRISODIUM ETHYLENEDIAMINE DISUCCINATE, CITRIC ACID, DIETHYLHEXYL SODIUM SULFOSUCCINATE, CARBOMER, SODIUM HYDROXIDE, ETHYLHEXYLGLYCERIN, CITRUS GRANDIS (GRAPEFRUIT) SEED EXTRACT, ECHINACEA ANGUSTIFOLIA EXTRACT, DIMETHICONE, ARCTIUM LAPPA ROOT EXTRACT, PHENOXYETHANOL, OLEANOLIC ACID, PEG-40 STEARATE, SILICA, SORBITAN STEARATE, TOCOPHEROL
Dosage & Administration
Clean the skin thoroughly before applying this product.
Cover the entire affected area with a thin layer one to three times daily.
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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
Package Label.Principal Display Panel
Label (102524 At Acnebpogel Primary Page 0001)
* Please review the disclaimer below.
