CERAVE ACNE FOAMING CLEANSER- benzoyl peroxide cream

CeraVe Acne Foaming Cleanser by

Drug Labeling and Warnings

CeraVe Acne Foaming Cleanser by is a Otc medication manufactured, distributed, or labeled by L'Oreal USA Products Inc, PakLab. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzoyl peroxide 4%

Purpose

Acne treatment

Use

for the treatment of acne

Warnings

For external use only

Do not use if you

• have 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

skin irritation becomes severe

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

use every morning and evening
apply a dime-size amount to damp skin and gently massage, avoiding the eye area
rinse wel
use wash on entire affected area one to two 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
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, glycerin, propylene glycol, cocamidopropyl hydroxysultaine, sodium c14-16 olefin sulfonate, xanthan gum, potassium hydroxide, ceramide NP, ceramide AP, ceramide EOP, carbomer, niacinamide, glycolic acid, sodium chloride, sodium citrate, sodium hyaluronate, sodium lauroyl lactylate, sodium hydroxide, cholesterol, phenoxyethanol, propanediol, citric acid, tetrasodium EDTA, diethylhexyl sodium sulfosuccinate, phytosphingosine, ethylhexylglycerin, benzoic acid

Other information

store at 20° - 25°C (68° to 77°F)

Questions orcomments?

Toll-free number 1-888-768-2915

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CERAVE ACNE FOAMING CLEANSER 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49967-238
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
XANTHAN GUM (UNII: TTV12P4NEE)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
CERAMIDE NP (UNII: 4370DF050B)
CERAMIDE AP (UNII: F1X8L2B00J)
CERAMIDE 1 (UNII: 5THT33P7X7)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
NIACINAMIDE (UNII: 25X51I8RD4)
GLYCOLIC ACID (UNII: 0WT12SX38S)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CHOLESTEROL (UNII: 97C5T2UQ7J)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPANEDIOL (UNII: 5965N8W85T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
EDETATE SODIUM (UNII: MP1J8420LU)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
BENZOIC ACID (UNII: 8SKN0B0MIM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49967-238-01	1 in 1 CARTON	12/01/2021
1		150 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 49967-238-02	15 in 1 CARTON	12/01/2021
2		10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	12/01/2021

Labeler - L'Oreal USA Products Inc (002136794)

Establishment
Name	Address	ID/FEI	Business Operations
Accupac, LLC		061595175	MANUFACTURE(49967-238)