Label: GLYTONE ACNE BPO CLEARING CLEANSER- benzoyl peroxide lotion
- NDC Code(s): 64760-712-01
- Packager: Pierre Fabre USA Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Updated January 1, 2021
If you are a consumer or patient please visit this version.
- Drug Facts
- Active Ingredients
For external use only.
When using this product
- skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
- avoid unnecessary sun exposure and use a sunscreen
- avoid contact with the eyes, lips, and mouth
- avoid contact with hair and dyed fabrics, which may be bleached by this product
- skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration.
- Dispense a small amount into hand and mix with a little water.
- Apply a thin layer over entire affected area in a circular motion, rinse thoroughly with warm water two times daily.
- Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two times or as directed by a doctor.
- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
- If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.
- Other information
WATER, COCAMIDOPROPYL BETAINE, SODIUM C14-16 OLEFIN SULFONATE, HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE, DIPROPYLENE GLYCOL, 1,3-BUTYLENE GLYCOL, BUTYROSPERMUM PARKII (SHEA) BUTTER, XANTHAN GUM, EUPHORBIA CERIFERA (CANDELILLA) WAX, HYDROXYPROPYL METHYLCELLULOSE, PHENOXYETHANOL, ETHYLHEXYLGLYCERIN, PEG-11 AVOCADO GLYCERIDES
- Principal Display Panel - 200 ml Bottle
INGREDIENTS AND APPEARANCE
GLYTONE ACNE BPO CLEARING CLEANSER
benzoyl peroxide lotion
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:64760-712 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE 45 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH) DIPROPYLENE GLYCOL (UNII: E107L85C40) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) SHEA BUTTER (UNII: K49155WL9Y) XANTHAN GUM (UNII: TTV12P4NEE) CANDELILLA WAX (UNII: WL0328HX19) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) PHENOXYETHANOL (UNII: HIE492ZZ3T) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PEG-11 AVOCADO GLYCERIDES (UNII: YLY4A64409) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:64760-712-01 200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 03/01/2017 Labeler - Pierre Fabre USA Inc. (117196928)