NUJEVI ACNE- benzoyl peroxide cream

NUJEVI ACNE by

Drug Labeling and Warnings

NUJEVI ACNE by is a Otc medication manufactured, distributed, or labeled by COSMOCEUTICAL RESEARCH CENTER INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT:
BENZOYL PEROXIDE 2.5%

PURPOSE

PURPOSE:
ANTIBACTERIAL

INDICATIONS & USAGE

USES: HELPS TO CONTROL ACNEIC SKIN CONDITIONS. PREVENTS ACNE RECURRENCE.

WARNINGS

Warning:
For external use only.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

OTHER SAFETY INFORMATION

This product may bleach hair or dyed fabrics.
Do not use on broken skin and if sensitive to benzoyl peroxide.
Apply sunscreen when using this product in the morning.

DOSAGE & ADMINISTRATION

Dosage and Administration:
Apply a small amount on clean skin once a day, only on affected areas.

STORAGE AND HANDLING

Storage Conditions: Store at room temperature.

INACTIVE INGREDIENT

Other Ingredients: aqua, ethoxydiglycol, bentonite, cyclodextrin, melaleuca alternifolia leaf oil, peg-100 stearate, glyceryl stearate, xanthan gum, allantoin, caprylyl glycol, phenoxyethanol, isopentyldiol, peg-75 stearyl ether dimer ipdi, usnic acid.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

NUJEVI ACNE 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66538-401
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	2.5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
BENTONITE (UNII: A3N5ZCN45C)
GAMMA CYCLODEXTRIN (UNII: KZJ0BYZ5VA)
TEA TREE OIL (UNII: VIF565UC2G)
PEG-100 STEARATE (UNII: YD01N1999R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
XANTHAN GUM (UNII: TTV12P4NEE)
ALLANTOIN (UNII: 344S277G0Z)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ISOPENTYLDIOL (UNII: 19NOL5474Q)
DISTEARETH-75 ISOPHORONE DIISOCYANATE (UNII: 5365FJ30SC)
USNIC ACID (UNII: 0W584PFJ77)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66538-401-22	60 g in 1 BOTTLE; Type 0: Not a Combination Product	08/28/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	08/28/2014

Labeler - COSMOCEUTICAL RESEARCH CENTER INC (160019006)

Registrant - COSMOCEUTICAL RESEARCH CENTER INC (160019006)