Naturium Benzoyl Peroxide Cream Cleanser 5%

Benzoyl Peroxide by

Drug Labeling and Warnings

Benzoyl Peroxide by is a Otc medication manufactured, distributed, or labeled by The Center Brands, LLC, DIMENSIONAL MERCHANDISING INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BENZOYL PEROXIDE- naturium benzoyl peroxide cream cleanser 5% cream 
The Center Brands, LLC

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Naturium Benzoyl Peroxide Cream Cleanser 5%


Active Ingredient Purpose
Benzoyl Peroxide 5.00%...........................Acne Treatment


Do not use on
broken skin
large areas of the skin


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

Keep out of reach of children.


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.
If irritation occurs, only use one topical acne medication
at a time.
Do not use on
broken skin
large areas of the skin
When using this product
apply only to areas with acne
Avoid eye area.
In case of eye contact, flush gently and thoroughly
with water.
Keep out of reach of children.


Directions
apply a dime size amount and gently massage on damp
skin to clean the skin thoroughly. Avoid eye area. Rinse
well.
cleanse the entire affected area one to three times daily
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.


Directions
apply a dime size amount and gently massage on damp
skin to clean the skin thoroughly. Avoid eye area. Rinse
well.
cleanse the entire affected area one to three times daily
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.

carton

BENZOYL PEROXIDE 
naturium benzoyl peroxide cream cleanser 5% cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 82800-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 82800-001-01147 g in 1 BOTTLE; Type 0: Not a Combination Product06/17/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00606/17/202201/09/2024
Labeler - The Center Brands, LLC (076228814)
Establishment
NameAddressID/FEIBusiness Operations
Paklab177711082manufacture(82800-001)

Revised: 1/2024
 

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