AVENE CLEANANCE ACNE MEDICATED CLEARING TREATMENT- benzoyl peroxide liquid

Avene Cleanance Acne Medicated Clearing Treatment by

Drug Labeling and Warnings

Avene Cleanance Acne Medicated Clearing Treatment by is a Otc medication manufactured, distributed, or labeled by Pierre Fabre USA Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Purpose

Acne Treatment

Active Ingredient

BENZOYL PEROXIDE 5.5%

Uses

For the treatment of acne.

Dries and clears acne blemishes and allows skin to heal.

Helps keep skin clear of new acne blemishes

Warnings

For external use only.

Do not use if you

have very sensitive skin or 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

clean the skin thoroughly before applying this product.

cover the entire affected area with a thin layer one to three times daily.

because excessive dry of the skin may occur, start with one application daily, then gradually increase to two or three times daily needed 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.

Inactive Ingredients

Water (aqua), propanediol, dimethyl isosorbide, glycerin, 1,2-hexanediol, acrylamide/sodium acryloyldimethyllurate copolymer, isohexadecane, hydroxyacetophenone, hylocereus undatus fruit extract, polysorbate 80, polyglyceryl-2 isostearate, xanthan gum, sodium citrate, trisodium ethylenediamine disuccinate, citric acid, diethylhexyl sodium sulfosuccinate, carbomer, sodium hydroxide, hyaluronic acid, ethylhexylglycerin, morinda citrifolia extract, phenoxyethanol, dimethicone, sodium metabisulfite, peg-40 stearate, silica, sorbitan stearate, tocopherol

Questions

1-866-41-AVENE (28363)

Packaging

EAU THERMALE

AVENE

LABORATORIE DERMATOLOGIQUE

CLEANANCE

ACNE

MEDICATED CLEARING

TREATMENT

ACNE MEDICATED CREAM

[BENZOYL PEROXIDE 5.5%

FOR OILY, ACNE-PRONE,

SENSITIVE SKIN

REDUCES THE SEVERITY AND HELPS PREVENT NEW ACNE BLEMISHES, PIMPLES AND BLACKHEADS FROM FORMING

40 ML / 1.3 FL.OZ.

INGREDIENTS AND APPEARANCE

AVENE CLEANANCE ACNE MEDICATED CLEARING TREATMENT 
benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 64760-776
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5.5 mg  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS)
HYLOCEREUS UNDATUS FRUIT (UNII: WUG58TD53X)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
CARBOMER 1342 (UNII: 809Y72KV36)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYALURONIC ACID (UNII: S270N0TRQY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-40 STEARATE (UNII: ECU18C66Q7)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TOCOPHEROL (UNII: R0ZB2556P8)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
MORINDA CITRIFOLIA FRUIT (UNII: 7829X3G2X5)
PEG-20 SORBITAN STEARATE (UNII: HD40WR33LC)
ISOHEXADECANE (UNII: 918X1OUF1E)
POLYGLYCERYL-2 ISOSTEARATE (UNII: 7B8OE71MQC)
DIHEXYL SODIUM SULFOSUCCINATE (UNII: 7YY1T561V4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 64760-776-01	1 in 1 CARTON	05/30/2023
1		5 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 64760-776-02	1 in 1 CARTON	05/30/2023
2		40 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	05/30/2023

Labeler - Pierre Fabre USA Inc. (117196928)

Registrant - Pierre Fabre USA Inc. (117196928)