EXODEN POWDER- cetylpyridinium chloride, domiphen bromide powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOMIPHEN BROMIDE (UNII: R4CY19YS7C) (DOMIPHEN - UNII:4AZL56CU0F), CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3)

Available from:

LIFEON Corp.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Oral Health Care Provide better health to teeth and gums

Authorization status:

unapproved drug other

Summary of Product characteristics

EXODEN POWDER- CETYLPYRIDINIUM CHLORIDE, DOMIPHEN BROMIDE POWDER
LIFEON CORP.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
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70602-001EXODEN POWDER
Cetylpyridinium Chloride(CPC) 0.425%
Domiphen Bromide 0.120
Oral Health Care
Provide better health to teeth and gums
Wet your toothbrush, shake off surplus water and press into powder.
Brush teeth thoroughly and rinse
Ask a dentist before use if you have
• bleeding or redness lasting more than 2 weeks
• pain, swelling, pus, loose teeth, or more spacing between teeth
These may be signs of periodontitis, a serious form of gum disease
Keep out of reach of children under 6 years of age. If more than used
for brushing is accidentally
swallowed, get medical help or contact a Poison Control Center right
away
Bentonite, Sodium Chloride(Bamboo Salts), L-Menthol
LIFEON Corp.
EXODEN POWDER
cetylpyridinium chloride, domiphen bromide powder
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:70 6 0 2-0 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DO MIPHEN BRO MIDE (UNII: R4CY19 YS7C) (DOMIPHEN - UNII:4AZL56 CU0 F)
DOMIPHEN BROMIDE
0 .3 in 70 g
CETYLPYRIDINIUM CHLO RIDE (UNII: D9 OM4SK49 P) (CETYLPYRIDINIUM -
UNII:CUB7JI0 JV3)
CETYLPYRIDINIUM
CHLORIDE
0 .0 8 4 g
in 70 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
BENTO NITE (UNII: A3N5ZCN45C)
SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)
MENTHO L, UNSPECIFIED FO RM (UNII: L7T10 EIP3A)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:70 6 0 2-0 0 1-0 2 1 in 1 CARTON
0 4/0 7/20 16
1
NDC:70 6 0 2-0 0 1-0 1 70 g in 1 CONTAINER; Type 0 : No t a Co
mbinatio n Pro duct
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
unappro ved drug o ther
0 4/0 7/20 16
LABELER -
LIFEON Corp. (68852887