NATURIUM BENZOYL PEROXIDE CLEANSER 5%- benzoyl peroxide cream

Naturium Benzoyl Peroxide Cleanser 5% by

Drug Labeling and Warnings

Naturium Benzoyl Peroxide Cleanser 5% by is a Otc medication manufactured, distributed, or labeled by e.l.f. Cosmetics, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzoyl Peroxide 5.00%

Purpose

Acne Treatment

Uses

• Helps fight existing acne breakouts and prevents future acne breakouts.

Warnings

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.

Do not use if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

Stop use and ask a doctor if

• irritation becomes severe

​Keep out of reach of children.

​Keep out of reach of children.

Directions

Shake Well.

• gently massage a dime size amount on damp skin to cleanse thoroughly. Avoid eye area.
• cover the entire affected area and rinse thoroughly.
• because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or two 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.

Other Information

Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above. Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightly closed.

Inactive Ingredients

Aqua (Water), Sodium Cocoyl Isethionate, Cocamidopropyl Betaine, Glycerin, Cocamidopropyl Hydroxysultaine, Acetyl Glucosamine, Aloe Barbadensis Leaf Juice, Sodium Methyl Cocoyl Taurate, Xylitol, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Phenoxyethanol, Sodium Benzoate, Sodium Phosphate, Sodium Citrate, Propanediol, Diethylhexyl Sodium Sulfosuccinate, Carbomer, Sodium Hydroxide.

Product Packaging

INGREDIENTS AND APPEARANCE

NATURIUM BENZOYL PEROXIDE CLEANSER 5% 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76354-123
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
XYLITOL (UNII: VCQ006KQ1E)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PROPANEDIOL (UNII: 5965N8W85T)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
GLYCERIN (UNII: PDC6A3C0OX)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SODIUM PHOSPHATE (UNII: SE337SVY37)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76354-123-01	1 in 1 CARTON	06/17/2022
1		147 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	06/17/2022

Labeler - e.l.f. Cosmetics, Inc (093902816)