GLYTONE ACNE BPO CLEARING CLEANSER- benzoyl peroxide lotion 
Pierre Fabre USA Inc.

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.

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GLYTONE Acne BPO Clearing Cleanser

Drug Facts

Active Ingredients

Benzoyl Peroxide 4.5%

Purpose

Acne Treatment

Use

For the treatment of acne.

Warnings

For external use only.


Do not use if you

  • have a very sensitive skin
  • are sensitive to benzoyl peroxide

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.

Stop use and ask a doctor if irritation becomes severe.

Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away.

Directions

  • 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

Store at room temperature 68-77 o F (25-25 o C). Protect this product from excessive heat and direct sun.

Inactive ingredients

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

BPO Clearing Cleanser

GLYTONE

Acne BPO Clearing

Cleanser

4.5

Encapsulated Benzoyl Peroxide

200 mL / 6.7 FL. OZ.

GLYTONE ACNE BPO CLEARING CLEANSER 
benzoyl peroxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-712
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE45 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64760-712-01200 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product03/01/201712/16/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D03/01/201712/16/2023
Labeler - Pierre Fabre USA Inc. (117196928)

Revised: 3/2023
Document Id: f80d325d-d00c-bd3a-e053-6294a90a690d
Set id: f49659d5-fec4-43b4-9dca-9d4c365ec069
Version: 6
Effective Time: 20230329
 
Pierre Fabre USA Inc.