GLYTONE ACNE BPO TREATMENT GEL- benzoyl peroxide gel gel

Glytone Acne BPO Treatment Gel by

Drug Labeling and Warnings

Glytone Acne BPO Treatment Gel by is a Otc medication manufactured, distributed, or labeled by Glytone, LLC, Covalence Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Medicated, non-whitening lotion helps fight existing acne and prevent future breakouts from forming while calming visible redness.

ACTIVE INGREDIENT

BENZOYL PEROXIDE 5%

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.

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GLYTONE ACNE BPO TREATMENT GEL 
benzoyl peroxide gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84262-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ISOHEXADECANE (UNII: 918X1OUF1E)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)
XANTHAN GUM (UNII: TTV12P4NEE)
ANNICKIA CHLORANTHA BARK (UNII: H70115MP4A)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
DIETHYLHEXYL SODIUM SULFOSUCCINATE (UNII: F05Q2T2JA0)
CARBOMER (UNII: 0A5MM307FC)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CITRUS GRANDIS (GRAPEFRUIT) PEEL (UNII: 5NX3G75CA6)
ECHINACEA ANGUSTIFOLIA ROOT (UNII: D982V7VT3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
PEG-40 STEARATE (UNII: ECU18C66Q7)
SORBITAN STEARATE (UNII: NVZ4I0H58X)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
TOCOPHEROL (UNII: R0ZB2556P8)
ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (120000 MPA.S AT 1%) (UNII: 5F4963KLHS)
CITRIC ACID (UNII: 2968PHW8QP)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDRATED SILICA (UNII: Y6O7T4G8P9)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84262-030-01	60 g in 1 TUBE; Type 0: Not a Combination Product	04/02/2026

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	04/02/2026

Labeler - Glytone, LLC (119226548)

Registrant - Glytone, LLC (119226548)

Establishment
Name	Address	ID/FEI	Business Operations
Covalence Laboratories, Inc		959735002	manufacture(84262-030)