BENZOYL PEROXIDE gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)

Available from:

MD Formulation

INN (International Name):

BENZOYL PEROXIDE

Composition:

BENZOYL PEROXIDE 10 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph final

Summary of Product characteristics

BENZOYL PEROXIDE - BENZOYL PEROXIDE GEL
MD FORMULATION
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may be marketed if they_
_comply with applicable regulations and policies. FDA has not
evaluated whether this product complies._
----------
BENZOYL PEROXIDE 10&%
Benzoyl Peroxide 10%
Acne Treatment
Treats and helps prevent acne pimples.
Foe external use only
If swallowed, get medical help or contact a Poison Control Center
right away.
Directions Cleanse skin thoroughly before applying medication. Cover
the entire affected area with a
thin layer 1 to 3 times dally. Because excessive drying of the skin
may accur, start with 1 application
daily, then gradually increase to 2 to 3 times daily If needed or as
directed by a
physician. If bothersome dryness or peeling occurs, reduce application
to once a day or every other
other day.
Inactive Ingredients:
Water, glycerin, propylene glycol, carbomer, diazolidinyl urea,
methylparaben, propylparaben,
aminomethyl propanol.
BENZOYL PEROXIDE
benzoyl peroxide gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 6 0 78 -0 33
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BENZO YL PERO XIDE (UNII: W9 WZN9 A0 GM) (BENZOYL PEROXIDE - UNII:W9
WZN9 A0 GM)
BENZOYL PEROXIDE 10 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
CARBO MER 9 3 4 (UNII: Z135WT9 20 8 )
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
DIAZO LIDINYL UREA (UNII: H5RIZ3MPW4)
METHYLPARABEN (UNII: A2I8 C7HI9 T)
PRO PYLPARABEN (UNII: Z8 IX2SC1OH)
AMINO METHYLPRO PANO L (UNII: LU49 E6 6 26 Q)
GLYCERIN (UNII: PDC6 A3C0 OX)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 6 0 78 -0 33-0 2
54 in 1 CASE
1
1 in 1 CARTON
1
6 1.6 8 g in 1 CYLINDER
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph final
pa rt333D
0 9 /23/20 0 1
LABELER -
MD F